Trial Outcomes & Findings for S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma (NCT NCT00121186)

NCT ID: NCT00121186

Last Updated: 2012-04-03

Results Overview

PFS rate at 1 year.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
• Results posted on: 2012-04-03

Participant Flow

Participant milestones

Measure	Nonmyeloablative Allogeneic Stem Cell Transplant Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

Baseline characteristics by cohort

Measure	Nonmyeloablative Allogeneic Stem Cell Transplant n=1 Participants Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.
Age Continuous	47.2 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 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

PRIMARY outcome

Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

PFS rate at 1 year.

Outcome measures

Measure

Nonmyeloablative Allogeneic Stem Cell Transplant n=1 Participants Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.

Progression-free Survival

1 participants

PRIMARY outcome

Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

OS rate at 1 year.

Outcome measures

Measure

Nonmyeloablative Allogeneic Stem Cell Transplant n=1 Participants Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.

Overall Survival

1 participants

Adverse Events

Nonmyeloablative Allogeneic Stem Cell Transplant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nonmyeloablative Allogeneic Stem Cell Transplant n=1 participants at risk
Blood and lymphatic system disorders Hemoglobin	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Eye disorders Dry eye syndrome	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Gastrointestinal disorders Diarrhea	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Gastrointestinal disorders Nausea	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Investigations Leukocytes (total WBC)	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Investigations Lymphopenia	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Investigations Neutrophils/granulocytes (ANC/AGC)	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Investigations Platelets	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months
Skin and subcutaneous tissue disorders Dry skin	100.0% 1/1 • After transplant, and after every month of protocol treatment, for a maximum of 6 months

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place