Trial Outcomes & Findings for Autologous and Allogeneic Transplant for Relapsed Lymphoma (NCT NCT00802113)

NCT ID: NCT00802113

Last Updated: 2019-03-27

Results Overview

Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 1 year post-transplantation

Results posted on

2019-03-27

Participant Flow

Out of the 30 enrolled subjects, only 23 subjects received both MAC and AutoSCT and Reduced Intensity Conditioning (RIC) and allogeneic hematopoietic cell transplantation (AlloHCT). 7 subjects did not complete the transplantation and therefore were not included into data analysis.

Participant milestones

Participant milestones
Measure	Arm A - Family Donor Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Overall Study STARTED	6	17
Overall Study COMPLETED	6	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous and Allogeneic Transplant for Relapsed Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-transplantation

Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT)	4 Participants	12 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-transplantation

Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-transplantation

Total includes subjects with partial response and patients with stable disease, defined as \<50% reduction in measurable disease or the uninterrupted persistence of B symptoms.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 1 year post-transplantation

Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Time to Neutrophil Engraftment	16 days Interval 14.0 to 18.0	24 days Interval 14.0 to 45.0

SECONDARY outcome

Timeframe: Up to 1 year post-transplantation

Population: 1 subject under Arm A and 2 subject under Arm B did not have this data point collected and therefore 3 subjects were not included into analysis.

Following MAC AutoSCT, the median time to platelet recovery will be measured.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=5 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=15 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Time to Platelet Engraftment	22 days Interval 17.0 to 29.0	53 days Interval 3.0 to 159.0

SECONDARY outcome

Timeframe: Up to 1 year post-transplantation

Population: Subjects who completed RIC AlloHCT

The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on \>50% of skin, bilirubin 2-3 mg/dl, diarrhea \> 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome.

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD)	0 participants	7 participants

SECONDARY outcome

Timeframe: Up to 1 year post-transplantation

Status as subjects died post-AlloHCT

Outcome measures

Outcome measures
Measure	Arm A - Family Donor n=6 Participants Fludarabine and Busulfan: Patients who have a matched family (allogeneic) donor will go on to receive non-ablative therapy, followed by an infusion of donor stem cells; this is called an allogeneic peripheral blood stem cell transplant.	Arm B - Unrelated Cord Blood or Adult n=17 Participants Fludarabine, Busulfan and ATG: For patients who don't have a matched family donor, a cord blood search and unrelated adult search will be done at all of the cord blood banks and adult donor registries in the world.
Total Number of Subjects That Experienced Transplant-related Mortality (TRM)	2 participants	6 participants

Adverse Events

Arm A - Family Donor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Arm B - Unrelated Cord Blood or Adult

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prakash Satwani, MD

Columbia University

Phone: (212) 305-0223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place