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Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00534118
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Intervention Biological: donor lymphocytes
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multiple DLI Single DLI
Hide Arm/Group Description Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions accruals where the patient received only one donor lymphocyte infusion
Period Title: Overall Study
Started 17 22
Completed 17 22
Not Completed 0 0
Arm/Group Title Multiple DLI Single DLI Total
Hide Arm/Group Description Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions Accruals where the patient received only one donor lymphocyte infusion Total of all reporting groups
Overall Number of Baseline Participants 15 12 27
Hide Baseline Analysis Population Description
Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. >8 weeks between infusions per the protocol). DLIs which were given <8 weeks apart counted as one accrual.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
<=18 years
1
   6.7%
1
   8.3%
2
   7.4%
Between 18 and 65 years
12
  80.0%
9
  75.0%
21
  77.8%
>=65 years
2
  13.3%
2
  16.7%
4
  14.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 12 participants 27 participants
45
(16 to 66)
53.5
(9 to 68)
51
(9 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Female
5
  33.3%
2
  16.7%
7
  25.9%
Male
10
  66.7%
10
  83.3%
20
  74.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
12
 100.0%
27
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
American Indian or Alaska Native
1
   6.7%
0
   0.0%
1
   3.7%
Asian
1
   6.7%
0
   0.0%
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
13
  86.7%
12
 100.0%
25
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 12 participants 27 participants
15 12 27
Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 12 participants 27 participants
Acute Myeloid Leukemia
8
  53.3%
9
  75.0%
17
  63.0%
Myelodysplastic Syndrome
2
  13.3%
0
   0.0%
2
   7.4%
Non Hodgkin Leukemia
2
  13.3%
1
   8.3%
3
  11.1%
Acute Lymphoblastic Leukemia
1
   6.7%
0
   0.0%
1
   3.7%
Chronic Myeloid Leukemia
1
   6.7%
1
   8.3%
2
   7.4%
Hodgkin Lymphoma
1
   6.7%
0
   0.0%
1
   3.7%
Prolymphocytic Leukemia
0
   0.0%
1
   8.3%
1
   3.7%
1.Primary Outcome
Title Complete Remission Rate
Hide Description continued or induced complete remission after DLI
Time Frame 100 days post DLI
Hide Outcome Measure Data
Hide Analysis Population Description
Each accrual is evaluable independently, some patients in both the Multiple and Single DLI are accrued more than once; total unique patients in multiple DLI is 15 and in single DLI is 12
Arm/Group Title Multiple DLI Single DLI
Hide Arm/Group Description:
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
accruals where the patient received only one donor lymphocyte infusion
Overall Number of Participants Analyzed 17 22
Measure Type: Count of Participants
Unit of Measure: Participants
8
  47.1%
6
  27.3%
2.Primary Outcome
Title Duration of Complete Response in Months (Maximum 12)
Hide Description For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
Time Frame 1 year post DLI
Hide Outcome Measure Data
Hide Analysis Population Description
Accruals which achieved a continued or induced complete remission at Day +100 after DLI, patients are censored at death in remission or at time of subsequent DLI
Arm/Group Title Multiple DLI - Complete Responders Single DLI - Complete Responders
Hide Arm/Group Description:
Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission
Duration of time patients who achieved a complete remission by day +100 after DLI maintained that remission
Overall Number of Participants Analyzed 8 6
Median (Full Range)
Unit of Measure: months
10.1
(1.7 to 12)
9
(1.0 to 12)
3.Secondary Outcome
Title Acute Graft-versus-host Disease
Hide Description development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Time Frame 100 days post DLI
Hide Outcome Measure Data
Hide Analysis Population Description
Each accrual is evaluable for acute GVHD grade III-IV
Arm/Group Title Multiple DLI Single DLI
Hide Arm/Group Description:
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
accruals where the patient received only one donor lymphocyte infusion
Overall Number of Participants Analyzed 17 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
  18.2%
Time Frame All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI and is the only SAE/AE captured per protocol
Adverse Event Reporting Description All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI
 
Arm/Group Title Multiple DLI Single DLI
Hide Arm/Group Description Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions accruals where the patient received only one donor lymphocyte infusion
All-Cause Mortality
Multiple DLI Single DLI
Affected / at Risk (%) Affected / at Risk (%)
Total   10/15 (66.67%)      7/12 (58.33%)    
Hide Serious Adverse Events
Multiple DLI Single DLI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      7/12 (58.33%)    
General disorders     
All cause mortality by 3 years after first DLI   10/15 (66.67%)  10 7/12 (58.33%)  7
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multiple DLI Single DLI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/12 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theresa Hahn
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
EMail: theresa.hahn@roswellpark.org
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00534118    
Other Study ID Numbers: CDR0000564827
RPCI-I-00703
First Submitted: September 20, 2007
First Posted: September 24, 2007
Results First Submitted: July 29, 2020
Results First Posted: August 26, 2020
Last Update Posted: August 26, 2020