Trial Outcomes & Findings for Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma (NCT NCT00005803)
NCT ID: NCT00005803
Last Updated: 2020-01-29
Results Overview
Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess "failure" rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Day 56
Results posted on
2020-01-29
Participant Flow
Participant milestones
| Measure |
Treatment (Tandem Transplantation)
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Tandem Transplantation)
n=76 Participants
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 56Population: Only includes patients who received allo transplant. One patient is excluded because they did not survive long enough to test for engraftment.
Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess "failure" rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease).
Outcome measures
| Measure |
Treatment (Tandem Transplantation)
n=53 Participants
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
Chemoresistant Group
Patients who were not CR or PR to most recent chemotherapy regimen.
|
Unknown Chemosensitivity Group
Patients who could not be evaluated for chemosensitivity.
|
|---|---|---|---|
|
Engraftment of HLA Identical PBSC Allografts
|
53 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autograftingPopulation: Although 54 patients received both auto transplant \& allo transplant, one patient did not survive to day 100.
The rates and accompanying confidence intervals associated with transplant-related mortality will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess "failure" rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease).
Outcome measures
| Measure |
Treatment (Tandem Transplantation)
n=53 Participants
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
Chemoresistant Group
Patients who were not CR or PR to most recent chemotherapy regimen.
|
Unknown Chemosensitivity Group
Patients who could not be evaluated for chemosensitivity.
|
|---|---|---|---|
|
Non-Relapse Mortality
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of autologous transplant until the time of death, assessed up to 3 yearsPopulation: One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.
Number of patients surviving by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.
Outcome measures
| Measure |
Treatment (Tandem Transplantation)
n=51 Participants
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
Chemoresistant Group
n=22 Participants
Patients who were not CR or PR to most recent chemotherapy regimen.
|
Unknown Chemosensitivity Group
n=2 Participants
Patients who could not be evaluated for chemosensitivity.
|
|---|---|---|---|
|
Overall Survival (OS)
6 Months
|
39 Participants
|
14 Participants
|
1 Participants
|
|
Overall Survival (OS)
1 Year
|
31 Participants
|
10 Participants
|
0 Participants
|
|
Overall Survival (OS)
1.5 Years
|
27 Participants
|
9 Participants
|
0 Participants
|
|
Overall Survival (OS)
2 Years
|
26 Participants
|
8 Participants
|
0 Participants
|
|
Overall Survival (OS)
3 Years
|
23 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of autologous transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, assessed up to 3 yearsPopulation: One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.
Number of patients surviving without disease by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.
Outcome measures
| Measure |
Treatment (Tandem Transplantation)
n=51 Participants
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
Chemoresistant Group
n=22 Participants
Patients who were not CR or PR to most recent chemotherapy regimen.
|
Unknown Chemosensitivity Group
n=2 Participants
Patients who could not be evaluated for chemosensitivity.
|
|---|---|---|---|
|
Progression Free-survival (PFS)
2 Years
|
25 Participants
|
8 Participants
|
0 Participants
|
|
Progression Free-survival (PFS)
6 Months
|
36 Participants
|
12 Participants
|
1 Participants
|
|
Progression Free-survival (PFS)
1 Year
|
27 Participants
|
8 Participants
|
0 Participants
|
|
Progression Free-survival (PFS)
1.5 Years
|
25 Participants
|
8 Participants
|
0 Participants
|
|
Progression Free-survival (PFS)
3 Years
|
22 Participants
|
8 Participants
|
0 Participants
|
Adverse Events
Treatment (Tandem Transplantation)
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Tandem Transplantation)
n=76 participants at risk
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
|---|---|
|
Infections and infestations
Bowel perforation and sepsis
|
1.3%
1/76 • Number of events 1
|
|
Infections and infestations
Sepsis with respiratory failure and mental status changes
|
1.3%
1/76 • Number of events 1
|
|
Infections and infestations
Tachycardia, intubation, sepsis and pulmonary embolus
|
1.3%
1/76 • Number of events 1
|
|
Infections and infestations
Death due to multiple pulmonary infections
|
1.3%
1/76 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary failure requiring intubation
|
2.6%
2/76 • Number of events 2
|
|
Infections and infestations
Death due to infection with pericardial and epicardial involvement
|
1.3%
1/76 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest due to disease progression
|
1.3%
1/76 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia due to organizing pneumonitis
|
1.3%
1/76 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia during PBSC infusion
|
1.3%
1/76 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.3%
1/76 • Number of events 1
|
|
Surgical and medical procedures
Intra-abdominal hemorrhage when undergoing VATS procedure
|
1.3%
1/76 • Number of events 1
|
|
General disorders
Seizures
|
1.3%
1/76 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Tandem Transplantation)
n=76 participants at risk
See Detailed Description
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation
Carmustine: Given IV
Cyclophosphamide: Given IV
Cyclosporine: Given PO
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation
Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion
Total-Body Irradiation: Undergo radiotherapy
|
|---|---|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
14.5%
11/76 • Number of events 11
|
|
Renal and urinary disorders
Increased Creatinine
|
21.1%
16/76 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.5%
8/76 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
7.9%
6/76 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place