Trial Outcomes & Findings for Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202) (NCT NCT00096460)
NCT ID: NCT00096460
Last Updated: 2023-01-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Three years post-Hematopoietic Stem Cell Transplant (HSCT)
Results posted on
2023-01-05
Participant Flow
Participant milestones
| Measure |
Autologous Hematopoietic Stem Cell Transplant (HSCT)
Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
|
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m\^2/day from day -6 to -4) fludarabine (30mg/m\^2/day from day -6 to -4)
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
8
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)
Baseline characteristics by cohort
| Measure |
Autologous Hematopoietic Stem Cell Transplant (HSCT)
n=22 Participants
Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
|
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
n=8 Participants
Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m\^2/day from day -6 to -4) fludarabine (30mg/m\^2/day from day -6 to -4)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
48 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
8 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Disease Status at Enrollment
First Relapse
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Second Relapse
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Third Relapse
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Second Partial Remission
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Third Partial Remission
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Second Complete Remission
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Disease Status at Enrollment
Third Complete Remission
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Number of Prior Therapies
|
2 Number of therapies
n=5 Participants
|
2 Number of therapies
n=7 Participants
|
2 Number of therapies
n=5 Participants
|
|
Months from diagnosis to transplant
|
39.8 months
n=5 Participants
|
28.9 months
n=7 Participants
|
33.6 months
n=5 Participants
|
PRIMARY outcome
Timeframe: Three years post-Hematopoietic Stem Cell Transplant (HSCT)Outcome measures
| Measure |
Autologous Hematopoietic Stem Cell Transplant (HSCT)
n=20 Participants
Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
|
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
n=7 Participants
Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m\^2/day from day -6 to -4) fludarabine (30mg/m\^2/day from day -6 to -4)
|
|---|---|---|
|
Lymphoma Progression-free Survival
|
13 participants
Interval 43.8 to 89.6
|
6 participants
Interval 63.3 to 100.0
|
Adverse Events
Autologous Hematopoietic Stem Cell Transplant (HSCT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Autologous Hematopoietic Stem Cell Transplant (HSCT)
n=20 participants at risk
Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
|
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
n=7 participants at risk
Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m\^2/day from day -6 to -4) fludarabine (30mg/m\^2/day from day -6 to -4)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • 3-years post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
14.3%
1/7 • Number of events 1 • 3-years post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place