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LMP-specific T-cells for Patients With Relapsed EBV-positive Lymphoma (ALCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00062868
Recruitment Status : Completed
First Posted : June 18, 2003
Results First Posted : February 7, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Helen Heslop, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin Disease
Non Hodgkin Lymphoma
Lymphoepithelioma
Leiomyosarcoma
Interventions Biological: LMP1/2 CTLs (ALCI - Group A)
Biological: LMP1/2 CTLs (ALCI - Group B)
Biological: LMP1/2 CTLs (ALCI - Group C)
Biological: LMP2 CTLs (ALSCER - Group A)
Biological: LMP2 CTLs (ALSCER - Group B)
Biological: LMP2 CTLs (ALSCER - Group C)
Biological: LMP1/2 CTLs (ALCI - Expansion - Group A)
Biological: LMP1/2 CTLs (ALCI - Expansion Group B)
Biological: LMP1/2 CTLs (ALCI - Expansion Group C)
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Hide Arm/Group Description

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Period Title: Dose Level 1
Started 3 0 0 3 0 0 4 0 0 3 0 0 3 0 0 3 0 0 16 2 3
Completed 1 0 0 1 0 0 1 0 0 3 0 0 2 0 0 3 0 0 7 2 1
Not Completed 2 0 0 2 0 0 3 0 0 0 0 0 1 0 0 0 0 0 9 0 2
Reason Not Completed
Death             2             0             0             2             0             0             3             0             0             0             0             0             0             0             0             0             0             0             7             0             1
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             2             0             1
Period Title: Dose Level 2
Started 0 6 0 0 3 0 0 0 0 0 4 0 0 3 0 0 3 0 0 0 0
Completed 0 3 0 0 1 0 0 0 0 0 3 0 0 2 0 0 0 0 0 0 0
Not Completed 0 3 0 0 2 0 0 0 0 0 1 0 0 1 0 0 3 0 0 0 0
Reason Not Completed
Death             0             3             0             0             2             0             0             0             0             0             1             0             0             0             0             0             2             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             1             0             0             0             0
Period Title: Dose Level 3
Started 0 0 3 0 0 0 0 0 0 0 0 5 0 0 3 0 0 4 0 0 0
Completed 0 0 1 0 0 0 0 0 0 0 0 4 0 0 2 0 0 3 0 0 0
Not Completed 0 0 2 0 0 0 0 0 0 0 0 1 0 0 1 0 0 1 0 0 0
Reason Not Completed
Death             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             1             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Withdrew             0             0             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI - Expansion Group A) LMP1/2 CTLs (ALCI - Expansion Group B) LMP1/2 CTLs (ALCI - Expansion Group C) Total
Hide Arm/Group Description

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2). Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2) Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant. Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2) Total of all reporting groups
Overall Number of Baseline Participants 3 6 3 3 3 0 4 0 0 3 4 5 3 3 3 3 3 4 16 2 3 74
Hide Baseline Analysis Population Description
The number of participants analyzed is zero if there were no participants treated in the arm/group/dose.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 6 participants 3 participants 3 participants 3 participants 0 participants 4 participants 0 participants 0 participants 3 participants 4 participants 5 participants 3 participants 3 participants 3 participants 3 participants 3 participants 4 participants 16 participants 2 participants 3 participants 74 participants
39
(32 to 49)
53
(19 to 69)
13
(7 to 15)
57
(7 to 66)
25
(17 to 52)
54
(26 to 59)
46
(21 to 69)
54
(18 to 79)
55
(28 to 62)
23
(18 to 34)
18
(14 to 38)
43
(24 to 64)
13
(10 to 43)
30
(14 to 33)
17.5
(6 to 51)
45
(6 to 78)
39
(31 to 47)
16
(12 to 23)
33.5
(6 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 3 participants 3 participants 3 participants 0 participants 4 participants 0 participants 0 participants 3 participants 4 participants 5 participants 3 participants 3 participants 3 participants 3 participants 3 participants 4 participants 16 participants 2 participants 3 participants 74 participants
Female
2
  66.7%
2
  33.3%
1
  33.3%
2
  66.7%
1
  33.3%
1
  25.0%
1
  33.3%
0
   0.0%
2
  40.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  33.3%
2
  66.7%
2
  50.0%
7
  43.8%
0
   0.0%
2
  66.7%
27
  36.5%
Male
1
  33.3%
4
  66.7%
2
  66.7%
1
  33.3%
2
  66.7%
3
  75.0%
2
  66.7%
4
 100.0%
3
  60.0%
3
 100.0%
3
 100.0%
2
  66.7%
2
  66.7%
1
  33.3%
2
  50.0%
9
  56.3%
2
 100.0%
1
  33.3%
47
  63.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 3 participants 3 participants 3 participants 0 participants 4 participants 0 participants 0 participants 3 participants 4 participants 5 participants 3 participants 3 participants 3 participants 3 participants 3 participants 4 participants 16 participants 2 participants 3 participants 74 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  20.0%
0
   0.0%
1
  33.3%
1
  33.3%
2
  66.7%
2
  66.7%
0
   0.0%
4
  25.0%
0
   0.0%
0
   0.0%
14
  18.9%
Not Hispanic or Latino
3
 100.0%
6
 100.0%
1
  33.3%
3
 100.0%
3
 100.0%
4
 100.0%
3
 100.0%
3
  75.0%
4
  80.0%
3
 100.0%
2
  66.7%
2
  66.7%
1
  33.3%
1
  33.3%
4
 100.0%
12
  75.0%
1
  50.0%
3
 100.0%
59
  79.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
1
   1.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 3 participants 3 participants 3 participants 0 participants 4 participants 0 participants 0 participants 3 participants 4 participants 5 participants 3 participants 3 participants 3 participants 3 participants 3 participants 4 participants 16 participants 2 participants 3 participants 74 participants
American Indian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
1
  33.3%
2
   2.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   6.8%
Black or African American
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
1
  50.0%
0
   0.0%
6
   8.1%
White
3
 100.0%
4
  66.7%
3
 100.0%
2
  66.7%
3
 100.0%
4
 100.0%
1
  33.3%
3
  75.0%
4
  80.0%
3
 100.0%
3
 100.0%
1
  33.3%
2
  66.7%
2
  66.7%
4
 100.0%
12
  75.0%
1
  50.0%
2
  66.7%
57
  77.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  33.3%
0
   0.0%
2
  12.5%
0
   0.0%
0
   0.0%
4
   5.4%
1.Primary Outcome
Title Dose Limiting Toxicity (DLT) Rate by the NCI Common Toxicity Criteria (CTCAE) v2.0 and the Method of Przepiorka et al (Protocol Appendix I)
Hide Description Dose limiting toxicity (DLT) rate is the proportion of participants with DLT. DLT will be defined as any toxicity that is irreversible, life threatening or Grade 3-4 considered to be primarily related to the LMP-specific cytotoxic T-lymphocytes (CTL) injection or development of Grade III-IV Graft versus host disease (GVHD). Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).
Time Frame 6 weeks post second CLT infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported for all DLT evaluable participants who received CTL infusions and either completed the DLT assessment period or dropped off the study early due to DLT. One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. DLT assessment data from the first enrollment is reported for this participant.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Hide Arm/Group Description:

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Overall Number of Participants Analyzed 3 6 3 3 3 0 3 0 0 3 3 4 3 3 3 3 3 4 15 2 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0
(0 to 0.708)
0
(0 to 0.459)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.602)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.708)
0
(0 to 0.602)
0
(0 to 0.218)
0
(0 to 0.842)
0
(0 to 0.842)
2.Secondary Outcome
Title Response Rate According to the Harmonization Project (Protocol 8.5.1) or RECIST Criteria.
Hide Description

Response rate is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) . All patients who receive the first infusion will be evaluable for response.

In patients with detectable tumors and/or lymphadenopathy - response and progression will be evaluated using PET based imaging studies (whenever possible) based on the Harmonization Project (protocol 8.5.1). All available non-PET imaging studies will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

Time Frame Up to 4 months after the last infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported for all participants who has received at least one infusion and has available response assessment data. One participant in LMP1/2 CTLs (ALCI) - Group A Expansion is excluded because of no available response data and one was enrolled to this arm/group twice that response assessment data from the first enrollment is reported.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Hide Arm/Group Description:

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Overall Number of Participants Analyzed 3 6 3 3 3 0 4 0 0 3 4 5 3 3 3 3 3 4 15 2 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.667
(0.094 to 0.992)
0.833
(0.359 to 0.996)
0.667
(0.094 to 0.992)
0.333
(0.008 to 0.906)
0.667
(0.094 to 0.992)
0.75
(0.194 to 0.994)
1
(0.292 to 1)
0.75
(0.194 to 0.994)
0.6
(0.147 to 0.947)
1
(0.292 to 1)
1
(0.292 to 1)
1
(0.292 to 1)
1
(0.292 to 1)
0.667
(0.094 to 0.992)
1
(0.398 to 1)
0.733
(0.449 to 0.922)
0.5
(0.013 to 0.987)
0.333
(0.008 to 0.906)
3.Secondary Outcome
Title Grade III-IV Toxicity Rate in Participants Receiving an Extended Dosage Regimen According to the NCI Common Toxicity Criteria (CTCAE) Version 2.0 and the Method of Przepiorka et. al. (Protocol Appendix I).
Hide Description Grade III-IV toxicity rate is defined as the proportion of participants who receive an extended dose regimen and developed Grade III-IV toxicity attributable to the CTL infusions at any time during the extended dosing regimen. Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).
Time Frame 6 weeks after the final injection
Hide Outcome Measure Data
Hide Analysis Population Description
Data is reported for participants who have received an extended dosage regimen.
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Hide Arm/Group Description:

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Overall Number of Participants Analyzed 2 1 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 1 0 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0
(0 to 0.842)
0
(0 to 0.975)
0
(0 to 0.975)
0
(0 to 0.975)
0
(0 to 0.975)
0
(0 to 0.975)
Time Frame Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 6 weeks after the last dosing of the study drug/biologic.
Adverse Event Reporting Description

Zeros in the number of participants at risk for Other/Serious Adverse Events and the number of participants at risk for All-Cause Mortality are due to no participants treated at those arms/groups.

One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. All adverse event data is included for this participant regardless of enrollment.

 
Arm/Group Title LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Hide Arm/Group Description

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/Lymphoepithelioma/ leiomyosarcoma or who are at risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 1 x 10^8 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 1 x 10^8 cells/m2, Day14: 2 x 10^8 cells/m2).

Group A: Participants receiving CTLs as therapy for relapsed Lymphoma/ Lymphoepithelioma/ leiomyosarcoma or who are at high risk for relapse.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group B: Participants receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

Group C: Participants receiving CTLs following allogeneic stem cell transplant.

Dose: Participants were administered 2 injections, 14 days apart (Day0: 2 x 10^7 cells/m2, Day14: 2 x 10^7 cells/m2).

All-Cause Mortality
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)      3/6 (50.00%)      0/3 (0.00%)      2/3 (66.67%)      2/3 (66.67%)      0/0      3/4 (75.00%)      0/0      0/0      0/3 (0.00%)      1/4 (25.00%)      1/5 (20.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      2/3 (66.67%)      1/4 (25.00%)      7/16 (43.75%)      0/2 (0.00%)      1/3 (33.33%)    
Hide Serious Adverse Events
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/6 (16.67%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      0/0      1/4 (25.00%)      0/0      0/0      0/3 (0.00%)      1/4 (25.00%)      1/5 (20.00%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      1/4 (25.00%)      3/16 (18.75%)      0/2 (0.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders                                           
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Cardiac disorders                                           
Nodal/junctional arrhythmia/dysrhythmia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Cardiac-ischemia/infarction  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
General disorders                                           
Fatigue (lethargy, malaise, asthenia)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations                                           
Wound-Infectious  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection without neutropenia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Investigations                                           
Bilirubin  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders                                           
Anorexia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Dehydration  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Hyponatremia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                           
Secondary Malignancy-Other  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
SecondaryMalignancy-Other:PERIPHERALPRIMITIVENEUROECTODERMALTUMOR/ EWINGSARCOMA  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
SecondaryMalignancy-Other:SpindleCellSarcoma-periaortic  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
SecondaryMalignancy-Other:Squamouscellcarcinoma  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders                                           
Dizziness/lightheadedness  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Neuropathy - Motor  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                                           
Adult respiratory distress syndrome (ARDS)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypoxia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders                                           
Uticaria (hives, welts, wheals)  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders                                           
Pulmonary-Other:pulmonaryembolism  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LMP2A CTLs (ALASCER) - Group A DL1 LMP2A CTLs (ALASCER) - Group A DL2 LMP2A CTLs (ALASCER) - Group A DL3 LMP2A CTLs (ALASCER) - Group B DL1 LMP2A CTLs (ALASCER) - Group B DL2 LMP2A CTLs (ALASCER) - Group B DL3 LMP2A CTLs (ALASCER) - Group C DL1 LMP2A CTLs (ALASCER) - Group C DL2 LMP2A CTLs (ALASCER) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A DL1 LMP1/2 CTLs (ALCI) - Group A DL2 LMP1/2 CTLs (ALCI) - Group A DL3 LMP1/2 CTLs (ALCI) - Group B DL1 LMP1/2 CTLs (ALCI) - Group B DL2 LMP1/2 CTLs (ALCI) - Group B DL3 LMP1/2 CTLs (ALCI) - Group C DL1 LMP1/2 CTLs (ALCI) - Group C DL2 LMP1/2 CTLs (ALCI) - Group C DL3 LMP1/2 CTLs (ALCI) - Group A Expansion LMP1/2 CTLs (ALCI) - Group B Expansion LMP1/2 CTLs (ALCI) - Group C Expansion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      6/6 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      0/0      4/4 (100.00%)      0/0      0/0      3/3 (100.00%)      4/4 (100.00%)      5/5 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      16/16 (100.00%)      2/2 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders                                           
Hemoglobin-Hgb  1  0/3 (0.00%)  0 2/6 (33.33%)  4 3/3 (100.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 3/4 (75.00%)  5 0/0  0 0/0  0 3/3 (100.00%)  3 1/4 (25.00%)  8 2/5 (40.00%)  6 1/3 (33.33%)  2 2/3 (66.67%)  4 1/3 (33.33%)  2 1/3 (33.33%)  1 2/3 (66.67%)  12 2/4 (50.00%)  8 7/16 (43.75%)  16 0/2 (0.00%)  0 2/3 (66.67%)  4
Transfusion: pRBCs  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  3 0/4 (0.00%)  0 1/16 (6.25%)  3 0/2 (0.00%)  0 0/3 (0.00%)  0
Transfusion; Platelets  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/4 (50.00%)  12 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Transfusion; pRBC's  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Febrile Neutropenia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Lymphatics-Other  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Lymphatics-Other:cervicaladenopathy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Cardiac disorders                                           
Sinus tachycardia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Palpitations  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Sinus Tachycardia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders                                           
Auditory/Hearing-Other  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Endocrine disorders                                           
Hypothyroidism  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Eye disorders                                           
Conjunctivitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Dry Eye  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Ocular-Visual Other  1  0/3 (0.00%)  0 2/6 (33.33%)  5 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Ocular/Visual-Other:Periorbitalerythemaandswelling  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Ocular/Visual-Other:Visionhaziness  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Tearing (watery eyes)  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders                                           
Constipation  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Diarrhea (without colostomy)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Diarrhea patients without colostomy  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  2 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Dyspepsia/Heartburn  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal-Other  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal-Other:erythemaofpharynx  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 1/6 (16.67%)  4 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  2 0/0  0 1/4 (25.00%)  2 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 3/16 (18.75%)  3 0/2 (0.00%)  0 1/3 (33.33%)  1
Pancreatitis  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 2/6 (33.33%)  3 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Abdominal Pain or Cramping  1  0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain or cramping  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 2/16 (12.50%)  3 0/2 (0.00%)  0 0/3 (0.00%)  0
Pain-Other:Oralpain  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
General disorders                                           
Edema  1  1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Constitutional Symptoms-Other  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/4 (50.00%)  3 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Fatigue (lethargy, malaise, asthenia)  1  0/3 (0.00%)  0 3/6 (50.00%)  5 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 4/4 (100.00%)  5 0/0  0 0/0  0 1/3 (33.33%)  4 0/4 (0.00%)  0 2/5 (40.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 4/16 (25.00%)  7 0/2 (0.00%)  0 1/3 (33.33%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 2/3 (66.67%)  3 0/4 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/16 (12.50%)  2 0/2 (0.00%)  0 1/3 (33.33%)  1
Fever-absence of Neutropenia  1  0/3 (0.00%)  0 3/6 (50.00%)  4 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/4 (50.00%)  4 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Rigors, chills  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Rigors/Chills  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Sweating (Diaphoresis)  1  1/3 (33.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Sweating (diaphoresis)  1  0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/16 (6.25%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Hemorrhage/Bleeding w/gr 3/4 Thrombocytopenia  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Chest Pain (non-cardiac, non-pleuritic)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Chest pain (non-cardiac and non-pleuritic)  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Pain-Other  1  0/3 (0.00%)  0 1/6 (16.67%)  1 2/3 (66.67%)  3 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 3/4 (75.00%)  9 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hepatobiliary disorders                                           
Hepatic-Other  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  2 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Immune system disorders                                           
Allergy/Immunology-Other:lymphnodeswelling  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Allergy/Immunology-Other:moresignificanthistaminereaction  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/4 (0.00%)  0 0/0  0 0/0  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/16 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations                                           
Wound-Infectious  1  0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/4 (25.00%)  1 0/0  0 0/0  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0