Trial Outcomes & Findings for Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant (NCT NCT00534118)
NCT ID: NCT00534118
Last Updated: 2020-08-26
Results Overview
continued or induced complete remission after DLI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
100 days post DLI
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
Multiple DLI
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
accruals where the patient received only one donor lymphocyte infusion
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
22
|
|
Overall Study
COMPLETED
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Multiple DLI
n=15 Participants
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
n=12 Participants
Accruals where the patient received only one donor lymphocyte infusion
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
n=5 Participants
|
53.5 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Disease
Acute Myeloid Leukemia
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Disease
Myelodysplastic Syndrome
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease
Non Hodgkin Leukemia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Disease
Acute Lymphoblastic Leukemia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease
Chronic Myeloid Leukemia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease
Hodgkin Lymphoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease
Prolymphocytic Leukemia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post DLIPopulation: 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
continued or induced complete remission after DLI
Outcome measures
| Measure |
Multiple DLI
n=17 Participants
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
n=22 Participants
accruals where the patient received only one donor lymphocyte infusion
|
|---|---|---|
|
Complete Remission Rate
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 1 year post DLIPopulation: 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
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)
Outcome measures
| Measure |
Multiple DLI
n=8 Participants
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
n=6 Participants
accruals where the patient received only one donor lymphocyte infusion
|
|---|---|---|
|
Duration of Complete Response in Months (Maximum 12)
|
10.1 months
Interval 1.7 to 12.0
|
9 months
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: 100 days post DLIPopulation: Each accrual is evaluable for acute GVHD grade III-IV
development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Outcome measures
| Measure |
Multiple DLI
n=17 Participants
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
n=22 Participants
accruals where the patient received only one donor lymphocyte infusion
|
|---|---|---|
|
Acute Graft-versus-host Disease
|
0 Participants
|
4 Participants
|
Adverse Events
Multiple DLI
Serious events: 10 serious events
Other events: 0 other events
Deaths: 10 deaths
Single DLI
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Multiple DLI
n=15 participants at risk
Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions
|
Single DLI
n=12 participants at risk
accruals where the patient received only one donor lymphocyte infusion
|
|---|---|---|
|
General disorders
All cause mortality by 3 years after first DLI
|
66.7%
10/15 • Number of events 10 • 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
All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI
|
58.3%
7/12 • Number of events 7 • 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
All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place