Trial Outcomes & Findings for Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma (NCT NCT02059239)

NCT ID: NCT02059239

Last Updated: 2021-02-21

Results Overview

Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

14 days after bendamustine treatment

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Chemo Plus Autologous Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Overall Study STARTED	18	16
Overall Study COMPLETED	16	13
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemo Plus Autologous Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Overall Study Progressive Disease after Bendamustine	1	3
Overall Study Physician Decision	1	0

Baseline Characteristics

Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemo Plus Autologous Transplantation n=18 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Total n=34 Participants Total of all reporting groups
Diagnosis Mantle Cell Lymphoma	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Diagnosis Transformed Diffuse Large B-Cell Lymphoma	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Diagnosis Peripheral T-Cell Lymphoma	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	12 Participants n=7 Participants	26 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants
Diagnosis Diffuse Large B-Cell Lymphoma	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Diagnosis Other	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Lines of Prior Therapy 2 Lines	11 Lines of Therapy n=5 Participants	3 Lines of Therapy n=7 Participants	14 Lines of Therapy n=5 Participants
Diagnosis Follicular Lymphoma	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Diagnosis Hodgkin's Disease	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Lines of Prior Therapy 3 Lines	4 Lines of Therapy n=5 Participants	3 Lines of Therapy n=7 Participants	7 Lines of Therapy n=5 Participants
Lines of Prior Therapy 4 Lines	1 Lines of Therapy n=5 Participants	5 Lines of Therapy n=7 Participants	6 Lines of Therapy n=5 Participants
Lines of Prior Therapy 5+ Lines	2 Lines of Therapy n=5 Participants	5 Lines of Therapy n=7 Participants	7 Lines of Therapy n=5 Participants

PRIMARY outcome

Timeframe: 14 days after bendamustine treatment

Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=18 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Number of Patients Able to Proceed to Transplant Proceeded to Transplant	16 Participants	13 Participants
Number of Patients Able to Proceed to Transplant Did Not Proceed to Transplant - Physician Decision	1 Participants	0 Participants
Number of Patients Able to Proceed to Transplant Did Not Proceed to Transplant - Progressive Disease	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 35 Days Post-Transplant

Population: 5 participants (2 from chemo + autologous transplant arm, 3 from chemo + allogeneic transplant arm) were unable to be analyzed for this outcome measure as they did not complete the study and did not receive an autologous or allogeneic transplant.

Proportion of patients who successfully achieve neutrophil engraftment after stem cell transplant, defined as an absolute neutrophil count of 500/mm3 or for three consecutive days.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Number of Patients Achieving Neutrophil Engraftment	16 Participants	13 Participants

PRIMARY outcome

Timeframe: 74 Days Post-Transplant

Proportion of patients who successfully achieve platelet engraftment after stem cell transplant, defined as a platelet count of \>20k/microL for three consecutive days without transfusion support for seven consecutive days.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Number of Patients Achieving Platelet Engraftment	16 Participants	12 Participants

SECONDARY outcome

Timeframe: From Day 0 until time of death, assessed up to 100 days post-transplant

The time from stem cell infusion (Day 0) to death from any cause.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Overall Survival at Day 100 Post-Transplant Alive	16 Participants	11 Participants
Overall Survival at Day 100 Post-Transplant Deceased	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 0 until time of death, assessed up to 365 days post-transplant

The time from stem cell infusion (Day 0) to death from any cause.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Overall Survival at Day 365 Post-Transplant Alive	16 Participants	6 Participants
Overall Survival at Day 365 Post-Transplant Deceased	0 Participants	7 Participants

SECONDARY outcome

Timeframe: From Day 0 until time of death, up to 100 days post-transplant.

Death due to any cause other than disease progression within first 100 days post-transplant.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Transplant-Related Mortality	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 14 days of salvage chemotherapy treatment

Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and \>50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease involvement) or progressive disease (PD; the appearance of any new lesion \>1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size), as per Cheson Criteria, following salvage chemotherapy with Bendamustine.

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=18 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Disease Response Following Salvage Chemotherapy Complete Remission	4 Participants	1 Participants
Disease Response Following Salvage Chemotherapy Partial Remission	8 Participants	6 Participants
Disease Response Following Salvage Chemotherapy Stable Disease	4 Participants	2 Participants
Disease Response Following Salvage Chemotherapy Progressive Disease	1 Participants	6 Participants
Disease Response Following Salvage Chemotherapy Not Assessed	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days after stem cell transplant

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Disease Response 30 Days Post-Transplant Progressive Disease	0 Participants	1 Participants
Disease Response 30 Days Post-Transplant Not Assessed	0 Participants	1 Participants
Disease Response 30 Days Post-Transplant Complete Remission	12 Participants	7 Participants
Disease Response 30 Days Post-Transplant Partial Remission	2 Participants	3 Participants
Disease Response 30 Days Post-Transplant Stable Disease	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year after stem cell transplant

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Disease Response at 1 Year Post-Transplant Complete Remission	12 Participants	4 Participants
Disease Response at 1 Year Post-Transplant Progressive Disease	3 Participants	2 Participants
Disease Response at 1 Year Post-Transplant Patient Deceased	0 Participants	7 Participants
Disease Response at 1 Year Post-Transplant Partial Remission	1 Participants	0 Participants
Disease Response at 1 Year Post-Transplant Stable Disease	0 Participants	0 Participants
Disease Response at 1 Year Post-Transplant Not Assessed	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Stem cell transplant (Day 0) up to 2 years post-transplant

Time elapsed between stem cell transplant (Day 0) and disease progression, as defined by the Cheson Criteria (the appearance of any new lesion \>1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size)

Outcome measures

Outcome measures
Measure	Chemo Plus Autologous Transplantation n=16 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Chemo Plus Allogeneic Transplantation n=13 Participants Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Progression-Free Survival After Stem Cell Transplant	NA Months Median progression-free survival was not reached in the chemo plus autologous transplantation group. An insufficient number of patients experienced progression/death within the follow-up interval to enable calculation of the median and both the upper and lower limits of the 95% confidence interval.	8 Months Interval 5.0 to 25.0

Adverse Events

Bendamustine

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Bendamustine Plus Autologous Transplantation

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Bendamustine Plus Allogeneic Transplantation

Serious events: 10 serious events

Other events: 13 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Bendamustine n=34 participants at risk Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days	Bendamustine Plus Autologous Transplantation n=16 participants at risk Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Autologous Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant	Bendamustine Plus Allogeneic Transplantation n=13 participants at risk Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Bendamustine: Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Carmustine: 300 mg/m2 on Day -6 Etoposide: 100 mg/m2 on days -5 to -2 Melphalan: 140mg/m2 on Day -1 Cytarabine: 200 mg/m2 on days -5 to -2 Alemtuzumab: 20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors Allogeneic Stem Cell Transplantation Rituximab: Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
Vascular disorders Hypotension	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Cardiac disorders Pericardial Effusion	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Cardiac disorders Heart Failure	2.9% 1/34 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	2.9% 1/34 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/13 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	15.4% 2/13 • Number of events 2 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Gastrointestinal disorders Intestinal Necrosis	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Infections and infestations Disseminated Adenovirus Infection	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Investigations Post-Transplant Lymphoproliferative Disorder	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	15.4% 2/13 • Number of events 2 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Investigations Chronic Graft versus Host Disease	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	7.7% 1/13 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Infections and infestations Sepsis	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/16 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	15.4% 2/13 • Number of events 2 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	6.2% 1/16 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	23.1% 3/13 • Number of events 3 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	6.2% 1/16 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	30.8% 4/13 • Number of events 4 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Blood and lymphatic system disorders Myelodysplastic Syndrome	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	6.2% 1/16 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/13 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.
Blood and lymphatic system disorders Acute Myeloid Leukemia	0.00% 0/34 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	6.2% 1/16 • Number of events 1 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.	0.00% 0/13 • Adverse events were assessed Day -24 (start of Bendamustine treatment) through 1 year post-transplant. All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0. 5 participants (2 autologous, 3 allogeneic) did not proceed to transplant and were not evaluable for adverse events on the Chemo Plus Autologous Transplant or Chemo Plus Allogeneic Transplant arms.

Other adverse events

Additional Information

Dr. Tsiporah Shore

Weill Cornell Medicine

Phone: 646-962-7950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place