Trial Outcomes & Findings for Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia (NCT NCT01008462)
NCT ID: NCT01008462
Last Updated: 2019-06-11
Results Overview
Number of patients surviving without relapsed/progressive disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 Year post-autograft
Results posted on
2019-06-11
Participant Flow
Participant milestones
| Measure |
Treatment (Autologous HCT, Donor HCT)
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 Year post-autograftNumber of patients surviving without relapsed/progressive disease
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Event-Free Survival (EFS)
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 year post-autograftRelapse/Progression defined as: Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies. Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Number of Patients With Relapsed/Progressive Disease
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year post-autograftNumber of patients surviving one year post-autograft
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Survival
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 year post-allograft,Population: Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.
aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=14 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
Acute Graft-versus-Host-Disease
|
8 Participants
|
|
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
Chronic extensive Graft-versus-Host-Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 200 days and 1 Year post-allograftPopulation: Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
Number of patients with non-relapse mortalities.
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=14 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Non-relapse Mortality (NRM)
200 days
|
0 Participants
|
|
Non-relapse Mortality (NRM)
1 Year
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 84 post-allograftPopulation: Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
Number of patients with donor engraftment.
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=14 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Number of Patients Who Engrafted
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-autograftNumber of patients who had infections.
Outcome measures
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 Participants
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Number of Patients Who Had Infections
|
16 Participants
|
Adverse Events
Treatment (Autologous HCT, Donor HCT)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 participants at risk
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
Other adverse events
| Measure |
Treatment (Autologous HCT, Donor HCT)
n=16 participants at risk
Allogeneic Bone Marrow Transplantation: Undergo donor HCT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT
Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT
Carmustine: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative study
Melphalan: Given IV
Mycophenolate Mofetil: Given PO
Peripheral Blood Stem Cell Transplantation: Undergo donor HCT
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
1/16 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
|
Additional Information
Dr. Mohamed L. Sorror
Fred Hutchinson Cancer Research Center
Phone: (206) 667-6298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place