Trial Outcomes & Findings for Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma (NCT NCT00574496)

Last Updated: 2023-09-28

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

1 year

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	High-Risk or Relapsed Hodgkin Lymphoma This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study. cyclophosphamide cyclosporine fludarabine phosphate gemcitabine hydrochloride ifosfamide mechlorethamine hydrochloride melphalan methotrexate mycophenolate mofetil prednisone procarbazine hydrochloride vincristine sulfate vinorelbine tartrate allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation umbilical cord blood transplantation total-body irradiation
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	High-Risk or Relapsed Hodgkin Lymphoma This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study. cyclophosphamide cyclosporine fludarabine phosphate gemcitabine hydrochloride ifosfamide mechlorethamine hydrochloride melphalan methotrexate mycophenolate mofetil prednisone procarbazine hydrochloride vincristine sulfate vinorelbine tartrate allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation umbilical cord blood transplantation total-body irradiation
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=25 Participants This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
Age, Continuous	35 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	5 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=24 Participants This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
Progression-free Survival at 1 Year	33.3 proportion of progression-free pts Interval 13.0 to 61.3

SECONDARY outcome

Timeframe: up to 8 years

Outcome measures

Outcome measures
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=24 Participants This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
Overall Survival	70.3 months Interval 51.5 to 96.1

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=24 Participants This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
Disease Relapse or Progression as Measured by CT Scan or PET	34.3 months Interval 13.2 to 56.7

Adverse Events

High-Risk or Relapsed Hodgkin Lymphoma

Serious events: 6 serious events

Other events: 2 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=24 participants at risk This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
General disorders Death not assoc w CTCAE term - Death NOS	8.3% 2/24 • Up to 8 years
General disorders Death not assoc w CTCAE term - Sudden Death	4.2% 1/24 • Up to 8 years
General disorders Fatigue	4.2% 1/24 • Up to 8 years
General disorders Fever	4.2% 1/24 • Up to 8 years
Vascular disorders Hematoma	4.2% 1/24 • Up to 8 years
Respiratory, thoracic and mediastinal disorders Hypoxia	4.2% 1/24 • Up to 8 years

Other adverse events

Other adverse events
Measure	High-Risk or Relapsed Hodgkin Lymphoma n=24 participants at risk This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
Skin and subcutaneous tissue disorders Rash/desquamation	4.2% 1/24 • Up to 8 years
Cardiac disorders Sinus tachycardia	4.2% 1/24 • Up to 8 years

Additional Information

Dr. Miguel-Angel Perales, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3757

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place