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Trial record 6 of 138 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Immunologic Factors"

Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia

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ClinicalTrials.gov Identifier: NCT00924170
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Results First Posted : September 8, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Kreitman, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult T-Cell Leukemia (ATL)
Interventions Drug: LMB-2
Drug: Fludarabine
Drug: Cyclophosphamide
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14. Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Period Title: Overall Study
Started 10 8
Completed 3 0
Not Completed 7 8
Reason Not Completed
Refused further treatment             0             1
Physician Decision             0             1
Progressive disease             3             6
Stopped due to neutralizing antibodies             3             0
Death             1             0
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients Total
Hide Arm/Group Description Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14. Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC). Total of all reporting groups
Overall Number of Baseline Participants 10 8 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
8
 100.0%
17
  94.4%
>=65 years
1
  10.0%
0
   0.0%
1
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 18 participants
42  (14.25) 39.8  (10.77) 40.9  (12.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Female
7
  70.0%
5
  62.5%
12
  66.7%
Male
3
  30.0%
3
  37.5%
6
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Hispanic or Latino
1
  10.0%
0
   0.0%
1
   5.6%
Not Hispanic or Latino
9
  90.0%
7
  87.5%
16
  88.9%
Unknown or Not Reported
0
   0.0%
1
  12.5%
1
   5.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African American Number Analyzed 10 participants 8 participants 18 participants
2
  20.0%
2
  25.0%
4
  22.2%
Tabago, Black Number Analyzed 10 participants 8 participants 18 participants
1
  10.0%
0
   0.0%
1
   5.6%
Peruvian, Hispanic Number Analyzed 10 participants 8 participants 18 participants
1
  10.0%
0
   0.0%
1
   5.6%
American from Jamaica, Black Number Analyzed 10 participants 8 participants 18 participants
1
  10.0%
0
   0.0%
1
   5.6%
Jamaican, Black Number Analyzed 10 participants 8 participants 18 participants
5
  50.0%
2
  25.0%
7
  38.9%
Ethiopian, Black Number Analyzed 10 participants 8 participants 18 participants
0
   0.0%
1
  12.5%
1
   5.6%
Jamaican Number Analyzed 10 participants 8 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
Barbados, Black Number Analyzed 10 participants 8 participants 18 participants
0
   0.0%
2
  25.0%
2
  11.1%
American, from Ghana, Black Number Analyzed 10 participants 8 participants 18 participants
0
   0.0%
1
  12.5%
1
   5.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 8 participants 18 participants
10
 100.0%
8
 100.0%
18
 100.0%
Prior Treatment   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
CHOP Number Analyzed 10 participants 7 participants 17 participants
2
  20.0%
3
  42.9%
5
  29.4%
EPOCH-C Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
C, ESHAP, PTX, Gem Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Medi507, Ontak, HAT Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
CHOP, C Number Analyzed 10 participants 7 participants 17 participants
2
  20.0%
0
   0.0%
2
  11.8%
EPOCH-RS Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
1
  14.3%
2
  11.8%
None Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Hydroxyurea Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
1
  14.3%
2
  11.8%
CHOP, Hydroxyurea Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
LSG-15, radiation Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
[1]
Measure Description: Prior treatments included cyclophosphamide, adriamycin, vincristine, and prednisone (CHOP), these 4 agents with etoposide (EPOCH) and campath (C or alemtuzumab, together EPOCH-C), etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP), pralatrexate (PTX), gemcitabine (Gem), siplizumab (Medi507), denileukin diftitox (Ontak), daclizumab or humanized anti-Tac (HAT) and EPOCH with rituximab and siplizumab (EPOCH-RS). The LSG-15 regimen includes prednisone, adriamycin, carmustine, etoposide, carboplatin, and vinorelbine.
[2]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Type of Leukemia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Acute Number Analyzed 10 participants 7 participants 17 participants
10
 100.0%
3
  42.9%
13
  76.5%
Lymphoma Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
4
  57.1%
4
  23.5%
[1]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Extravascular sites   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Bone, lung, skin Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
Thigh (skin) Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
Pelvis Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Muscle Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Skin Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Lymph node (LN) Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
2
  28.6%
3
  17.6%
Spleen, LN Number Analyzed 10 participants 7 participants 17 participants
2
  20.0%
1
  14.3%
3
  17.6%
Subcutaneous Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
1
  14.3%
2
  11.8%
None Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
Bone, subcutaneous Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
Spleen Number Analyzed 10 participants 7 participants 17 participants
2
  20.0%
0
   0.0%
2
  11.8%
[1]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Participants with High Lactate Hydrogenase (LDH)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 10 participants 7 participants 17 participants
10
 100.0%
7
 100.0%
17
 100.0%
No Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: High LDH is > 400 u/L.
[2]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Participants with High Calcium++   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 10 participants 7 participants 17 participants
5
  50.0%
2
  28.6%
7
  41.2%
No Number Analyzed 10 participants 7 participants 17 participants
5
  50.0%
5
  71.4%
10
  58.8%
[1]
Measure Description: High Calcium++ is a corrected calcium > 2.74
[2]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Adult T-cell Leukemia (ATL) cells/mm^3 in the Peripheral Blood   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 cells Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
3
  42.9%
3
  17.6%
1 cell Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
80 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
206 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
246 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
408 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
450 cells Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
687 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
5,604 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
7,737 cells Number Analyzed 10 participants 8 participants 18 participants
0
   0.0%
1
  12.5%
1
   5.6%
8,216 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
13,153 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
24,112 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
210,000 cells Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
213,000 cells Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
[1]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Maximum tumor size   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
<1 cm tumor Number Analyzed 10 participants 7 participants 17 participants
4
  40.0%
1
  14.3%
5
  29.4%
1.9 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
2 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
2.2 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
5.6 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
5.8 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
6 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
9 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
15, 2.5 cm tumor Number Analyzed 10 participants 7 participants 17 participants
0
   0.0%
1
  14.3%
1
   5.9%
17 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
17.5 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
18.5, 1.7 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
20, 1.8 cm tumor Number Analyzed 10 participants 7 participants 17 participants
1
  10.0%
0
   0.0%
1
   5.9%
[1]
Measure Description: Maximum tumor size is listed, respectively, with the maximum spleen diameter.
[2]
Measure Analysis Population Description: One participant was not evaluable. Participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
1.Primary Outcome
Title Percentage of Participants With a Minimally Durable Clinical Response Rate
Hide Description Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphoma and must last >8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All 10 patients receiving LMB-2 and at least 25+250 mg/m^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.

Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response.

Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Overall Response Number Analyzed 10 participants 5 participants
80
(44.4 to 97.5)
0
(0 to 0)
Complete Response Number Analyzed 10 participants 5 participants
60
(26 to 88)
0
(0 to 0)
Partial Response Number Analyzed 10 participants 5 participants
20
(2.5 to 55.6)
0
(0 to 0)
Stable Disease Number Analyzed 10 participants 5 participants
20
(2.5 to 55.6)
25
(3.2 to 65.1)
Progressive Disease Number Analyzed 10 participants 5 participants
0
(0 to 0)
37.5
(8.5 to 75.5)
Not Evaluable Number Analyzed 10 participants 5 participants
0
(0 to 0)
37.5
(8.5 to 75.5)
2.Secondary Outcome
Title Peak Level of LMB-2 in Adult T-Cell Lymphoma
Hide Description The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: ng/mL
602
(189 to 1072)
484
(205 to 748)
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.
Time Frame 70 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Median (95% Confidence Interval)
Unit of Measure: Months
11.6
(1.5 to 25.2)
1.05
(0.23 to 1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC, All Other Patients
Comments Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan Meier
Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.
Time Frame 70 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 7
Median (95% Confidence Interval)
Unit of Measure: Months
18.6
(2.3 to 53.0)
3.75
(1.3 to 16.0)
5.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 7 years and 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
8
 100.0%
6.Secondary Outcome
Title Number of Participants With Dose Limiting Toxicity (DLT)
Hide Description DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to <grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to <grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting <2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.
Time Frame 30 days after last dose of LMB2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders
Hide Description Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group.
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Median (Full Range)
Unit of Measure: pg/ml
Soluble CD25, lowest post-treatment (nadir) value Number Analyzed 10 participants 8 participants
1094
(0 to 113000)
34591
(5198 to 319000)
Median sCD25 Nadir for responders Number Analyzed 8 participants 0 participants
1082
(0 to 5999)
Median sCD25 Nadir for non-responders Number Analyzed 2 participants 8 participants
70713
(28425 to 113000)
34591
(5198 to 319000)
Median sCD25 PRE-treatment for responders Number Analyzed 8 participants 0 participants
31893
(3163 to 190000)
Median sCD25 PRE-treatment for non-responders Number Analyzed 2 participants 8 participants
66419
(5838 to 127000)
17079
(3668 to 122000)
8.Secondary Outcome
Title Area Under the Plasma Concentration (AUC) - LMB2
Hide Description AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: µg/-min/mL
161
(53.5 to 244)
144
(49.8 to 205)
9.Secondary Outcome
Title Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry
Hide Description Peripheral blood was obtained and analyzed by flow cytometry.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not have flow cytometry measuring it.
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Median (Full Range)
Unit of Measure: Cells/µL
Normal T-cells Number Analyzed 10 participants 8 participants
28
(6 to 87)
23.5
(1 to 156)
Normal CD4+ cells Number Analyzed 10 participants 7 participants
99.5
(4 to 427)
186
(1 to 3818)
Normal CD8+ cells Number Analyzed 10 participants 8 participants
28
(6 to 87)
23.5
(1 to 156)
Normal B-cells Number Analyzed 10 participants 8 participants
8
(0 to 119)
0.5
(0 to 11)
10.Secondary Outcome
Title Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2
Hide Description Blood was drawn prior to each cycle of LMB-2 to determine if the level, >75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(3.1 to 77)
0
(0 to 0)
11.Secondary Outcome
Title Duration of Response (Complete Response + Partial Response)
Hide Description Duration of response is defined as a response lasting for at least 4 weeks but >8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.
Time Frame 69 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 8
Median (95% Confidence Interval)
Unit of Measure: Weeks
69.6
(8 to 263)
0
(0 to 0)
12.Secondary Outcome
Title Plasma Clearance (CL) of LMB-2
Hide Description Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: mL/min
109
(10.9 to 134)
101
(13.5 to 191)
13.Secondary Outcome
Title Volume of Distribution of LMB-2
Hide Description Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: Liters
49.6
(3.3 to 313)
26.6
(4.89 to 133)
14.Secondary Outcome
Title Half Life (t1/2) of LMB-2
Hide Description Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Time Frame First 24 hours after the dose given on Cycle 2, day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description:
Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
Overall Number of Participants Analyzed 10 5
Median (Full Range)
Unit of Measure: min
360
(105 to 542)
251
(91.1 to 484)
15.Secondary Outcome
Title Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide
Hide Description Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death).
Time Frame 7 years and 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure is reported as in the publication noted in the References module.
Arm/Group Title Fludarabine and Cyclophosphamide: 20 + 200mg/m^2 Fludarabine and Cyclophosphamide: 25 + 250mg/m^2 Fludarabine and Cyclophosphamide: 30 + 300mg/m^2
Hide Arm/Group Description:
Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg.
All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg.
Patients CF08 and CF09, both received LMB-2 40 µg/kg
Overall Number of Participants Analyzed 3 12 2
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
2
  66.7%
10
  83.3%
2
 100.0%
Nausea/vomiting/anorexia
2
  66.7%
10
  83.3%
2
 100.0%
Fever/chills
1
  33.3%
10
  83.3%
1
  50.0%
Leukopenia/lymphopenia
1
  33.3%
9
  75.0%
2
 100.0%
Transaminases
3
 100.0%
8
  66.7%
1
  50.0%
Hypotension/tachycardia
1
  33.3%
8
  66.7%
2
 100.0%
Thrombocytopenia
1
  33.3%
8
  66.7%
2
 100.0%
Anemia
0
   0.0%
9
  75.0%
1
  50.0%
Myalgia/headache
2
  66.7%
7
  58.3%
2
 100.0%
Hypoalbuminemia
2
  66.7%
6
  50.0%
1
  50.0%
Hematuria
1
  33.3%
5
  41.7%
1
  50.0%
Proteinuria
0
   0.0%
7
  58.3%
0
   0.0%
Fatigue/dizziness
1
  33.3%
4
  33.3%
2
 100.0%
Edema
0
   0.0%
6
  50.0%
0
   0.0%
Abdominal pain
0
   0.0%
5
  41.7%
0
   0.0%
Diarrhea
1
  33.3%
3
  25.0%
0
   0.0%
Creatine phosphokinase (CPK)
0
   0.0%
4
  33.3%
0
   0.0%
Mucositis
0
   0.0%
3
  25.0%
1
  50.0%
Hypomagnesemia
0
   0.0%
3
  25.0%
0
   0.0%
Bilirubin
1
  33.3%
2
  16.7%
0
   0.0%
Alkaline phosphatase/gamma-glutamyl transferase
0
   0.0%
3
  25.0%
0
   0.0%
Pneumonitis
0
   0.0%
3
  25.0%
0
   0.0%
Low cluster of differentiation 4 (CD4) count
1
  33.3%
1
   8.3%
1
  50.0%
Lipase
0
   0.0%
3
  25.0%
0
   0.0%
Bladder infection
0
   0.0%
2
  16.7%
0
   0.0%
Dyspnea
0
   0.0%
2
  16.7%
0
   0.0%
Prothrombin time
1
  33.3%
1
   8.3%
0
   0.0%
Pruritis
1
  33.3%
0
   0.0%
1
  50.0%
16.Secondary Outcome
Title Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2
Hide Description Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 7 years and 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
*Grade 5 (death) event. Data for this outcome measure is reported as in the publication noted in the References module.
Arm/Group Title Fludarabine and Cyclophosphamide: 20 + 200mg/m^2 Fludarabine and Cyclophosphamide: 25 + 250mg/m^2 3Fludarabine and Cyclophosphamide: 0 + 300mg/m^2
Hide Arm/Group Description:
Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg
All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg
Patients CF08 and CF09, both received LMB-2 40 µg/kg
Overall Number of Participants Analyzed 3 12 2
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
1
  33.3%
9
  75.0%
2
 100.0%
Leukopenia/lymphopenia
1
  33.3%
9
  75.0%
2
 100.0%
Anemia
0
   0.0%
8
  66.7%
0
   0.0%
Transaminases
1
  33.3%
4
  33.3%
0
   0.0%
Thrombocytopenia
0
   0.0%
5
  41.7%
1
  50.0%
Fever/chills
0
   0.0%
3
  25.0%
1
  50.0%
Pneumonitis
0
   0.0%
3
  25.0%
0
   0.0%
Low cluster of differentiation 4 (CD4) count
1
  33.3%
1
   8.3%
1
  50.0%
Hypotension/tachycardia
0
   0.0%
2
  16.7%
0
   0.0%
Rectal hemorrhage
0
   0.0%
1
   8.3%
0
   0.0%
Bilirubin
0
   0.0%
1
   8.3%
0
   0.0%
Dysuria
0
   0.0%
1
   8.3%
0
   0.0%
Bladder infection
0
   0.0%
1
   8.3%
0
   0.0%
Hypoxia
0
   0.0%
1
   8.3%
0
   0.0%
Proteinuria
0
   0.0%
1
   8.3%
0
   0.0%
Sepsis*
0
   0.0%
1
   8.3%
0
   0.0%
Time Frame 7 years and 12 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Hide Arm/Group Description Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14. Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
All-Cause Mortality
Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)      6/8 (75.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      6/8 (75.00%)    
Cardiac disorders     
Cardiac arrest  1  1/10 (10.00%)  1 0/8 (0.00%)  0
General disorders     
Edema limbs  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Death related to disease  1  7/10 (70.00%)  7 6/8 (75.00%)  6
Infections and infestations     
Lung infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Sepsis  1 [1]  1/10 (10.00%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Dehydration  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Hypercalcemia  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Nervous system disorders     
Depressed level of consciousness  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Dizziness  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Presyncope  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Hypoxia  1  1/10 (10.00%)  1 0/8 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC All Other Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  8/10 (80.00%)  108 5/8 (62.50%)  16
Blood and lymphatic system disorders - Other,Prothrombin time prolonged  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Febrile neutropenia  1  3/10 (30.00%)  6 1/8 (12.50%)  1
Cardiac disorders     
Electrocardiogram QT corrected interval prolonged  1  2/10 (20.00%)  3 1/8 (12.50%)  1
Sinus tachycardia  1  4/10 (40.00%)  6 2/8 (25.00%)  2
Ear and labyrinth disorders     
Ear pain  1  0/10 (0.00%)  0 1/8 (12.50%)  1
External ear inflammation  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Endocrine disorders     
Hypothyroidism  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Eye disorders     
Blurred vision  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Conjunctivitis  1  2/10 (20.00%)  3 1/8 (12.50%)  1
Dry eye  1  2/10 (20.00%)  2 1/8 (12.50%)  1
Eye pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Floaters  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Papilledema  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Uveitis  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  5/10 (50.00%)  7 3/8 (37.50%)  4
Bloating  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Constipation  1  4/10 (40.00%)  6 2/8 (25.00%)  3
Diarrhea  1  5/10 (50.00%)  10 1/8 (12.50%)  1
Dyspepsia  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Dysphagia  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Mucositis oral  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Nausea  1  8/10 (80.00%)  23 6/8 (75.00%)  10
Oral pain  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Rectal hemorrhage  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Vomiting  1  6/10 (60.00%)  17 3/8 (37.50%)  6
General disorders     
Chills  1  5/10 (50.00%)  10 1/8 (12.50%)  1
Edema face  1  4/10 (40.00%)  8 0/8 (0.00%)  0
Edema limbs  1  7/10 (70.00%)  12 1/8 (12.50%)  1
Fatigue  1  5/10 (50.00%)  7 1/8 (12.50%)  1
Fever  1  10/10 (100.00%)  23 7/8 (87.50%)  7
Gait disturbance  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Pain  1  0/10 (0.00%)  0 1/8 (12.50%)  3
Immune system disorders     
Allergic reaction  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Infections and infestations     
Catheter related infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Infections and infestations - Other, CMV reaction  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Lung infection  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Mucosal infection  1  4/10 (40.00%)  4 0/8 (0.00%)  0
Rhinitis infective  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Sepsis  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Sinusitis  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Skin infection  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Tooth infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Urinary tract infection  1  3/10 (30.00%)  7 0/8 (0.00%)  0
Infections and Infestations - Other, Bladder  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Infections and infestations - Other, tooth infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications     
Vascular access complication  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Wound dehiscence  1  1/10 (10.00%)  1 5/8 (62.50%)  22
Investigations     
Activated partial thromboplastin time prolonged  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Alanine aminotransferase increased  1  5/10 (50.00%)  20 2/8 (25.00%)  2
Alkaline phosphatase increased  1  7/10 (70.00%)  9 3/8 (37.50%)  4
Aspartate aminotransferase increased  1  7/10 (70.00%)  44 5/8 (62.50%)  7
Blood bilirubin increased  1  5/10 (50.00%)  10 3/8 (37.50%)  3
CD4 lymphocytes decreased  1  2/10 (20.00%)  6 1/8 (12.50%)  2
CPK increased  1  5/10 (50.00%)  6 3/8 (37.50%)  4
Carbon monoxide diffusing capacity decreased  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Cardiac troponin I increased  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Creatinine increased  1  0/10 (0.00%)  0 2/8 (25.00%)  2
Fibrinogen decreased  1  2/10 (20.00%)  3 0/8 (0.00%)  0
GGT increased  1  4/10 (40.00%)  5 1/8 (12.50%)  1
Haptoglobin decreased  1  2/10 (20.00%)  2 1/8 (12.50%)  1
Hemoglobin increased  1  1/10 (10.00%)  1 0/8 (0.00%)  0
INR increased  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Investigations - Other, Bicarbonate, low; Bicarbonate, serum-low  1  1/10 (10.00%)  3 0/8 (0.00%)  0
Lipase increased  1  2/10 (20.00%)  2 3/8 (37.50%)  3
Lymphocyte count decreased  1  9/10 (90.00%)  136 5/8 (62.50%)  22
Neutrophil count decreased  1  9/10 (90.00%)  83 5/8 (62.50%)  23
Platelet count decreased  1  10/10 (100.00%)  100 4/8 (50.00%)  6
Serum amylase increased  1  4/10 (40.00%)  5 2/8 (25.00%)  2
Weight gain  1  2/10 (20.00%)  2 0/8 (0.00%)  0
White blood cell decreased  1  8/10 (80.00%)  155 0/8 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  5/10 (50.00%)  6 2/8 (25.00%)  2
Dehydration  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Hypercalcemia  1  3/10 (30.00%)  9 3/8 (37.50%)  4
Hyperglycemia  1  2/10 (20.00%)  6 3/8 (37.50%)  4
Hyperkalemia  1  3/10 (30.00%)  4 1/8 (12.50%)  1
Hypermagnesemia  1  3/10 (30.00%)  5 1/8 (12.50%)  1
Hypernatremia  1  3/10 (30.00%)  9 2/8 (25.00%)  2
Hypertriglyceridemia  1  3/10 (30.00%)  4 0/8 (0.00%)  0
Hyperuricemia  1  2/10 (20.00%)  3 0/8 (0.00%)  0
Hypoalbuminemia  1  7/10 (70.00%)  36 5/8 (62.50%)  6
Hypocalcemia  1  5/10 (50.00%)  39 0/8 (0.00%)  0
Hypoglycemia  1  2/10 (20.00%)  2 2/8 (25.00%)  2
Hypokalemia  1  4/10 (40.00%)  52 0/8 (0.00%)  0
Hypomagnesemia  1  6/10 (60.00%)  22 1/8 (12.50%)  1
Hyponatremia  1  8/10 (80.00%)  33 4/8 (50.00%)  4
Hypophosphatemia  1  6/10 (60.00%)  24 2/8 (25.00%)  2
Metabolism and nutrition disorders - Other, Bicarbonate, Low  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Back pain  1  4/10 (40.00%)  5 2/8 (25.00%)  2
Bone pain  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Buttock pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Chest wall pain  1  4/10 (40.00%)  5 0/8 (0.00%)  0
Myalgia  1  8/10 (80.00%)  16 1/8 (12.50%)  1
Myositis  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Neck pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Non-cardiac chest pain  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Pain in extremity  1  4/10 (40.00%)  12 3/8 (37.50%)  4
Nervous system disorders     
Dizziness  1  5/10 (50.00%)  7 0/8 (0.00%)  0
Dysphasia  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Encephalopathy  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Headache  1  7/10 (70.00%)  16 3/8 (37.50%)  5
Memory impairment  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Paresthesia  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Presyncope  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Seizure  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Sinus pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Somnolence  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Syncope  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Tremor  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Psychiatric disorders     
Agitation  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Anxiety  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Confusion  1  2/10 (20.00%)  3 1/8 (12.50%)  1
Depression  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Insomnia  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Renal and urinary disorders     
Hematuria  1  5/10 (50.00%)  10 2/8 (25.00%)  2
Proteinuria  1  6/10 (60.00%)  7 1/8 (12.50%)  1
Urinary incontinence  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Urinary tract pain  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Reproductive system and breast disorders     
Vaginal inflammation  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  2/10 (20.00%)  2 1/8 (12.50%)  1
Cough  1  3/10 (30.00%)  3 1/8 (12.50%)  1
Dyspnea  1  4/10 (40.00%)  7 0/8 (0.00%)  0
Epistaxis  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Hypoxia  1  2/10 (20.00%)  3 0/8 (0.00%)  0
Pharyngolaryngeal pain  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Pleural effusion  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Wheezing  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin  1  2/10 (20.00%)  2 0/8 (0.00%)  0
Photosensitivity  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Pruritus  1  6/10 (60.00%)  8 2/8 (25.00%)  2
Rash maculo-papular  1  5/10 (50.00%)  9 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders - Other,Dermatology/Skin: Rash  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Skin ulceration  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Vascular disorders     
Capillary leak syndrome  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Hot flashes  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Hypertension  1  1/10 (10.00%)  3 0/8 (0.00%)  0
Hypotension  1  9/10 (90.00%)  15 2/8 (25.00%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Kreitman
Organization: National Cancer Institute
Phone: 301-496-6947
EMail: Robert_Kreitman@nih.gov
Layout table for additonal information
Responsible Party: Robert Kreitman, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00924170     History of Changes
Obsolete Identifiers: NCT00794833
Other Study ID Numbers: 090025
09-C-0025
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: June 1, 2017
Results First Posted: September 8, 2017
Last Update Posted: February 26, 2019