S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
- Conditions
- Lymphoma
- Interventions
- Procedure: allogeneic bone marrow transplantationProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00121186
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the 1-year progression-free and overall survival rate in patients with relapsed Hodgkin's or non-Hodgkin's lymphoma after prior autologous stem cell transplantation treated with a nonmyeloablative conditioning regimen comprising fludarabine and melphalan followed by allogeneic bone marrow or peripheral blood stem cell transplantation and immunosuppression comprising tacrolimus and methotrexate.
* Determine treatment-related mortality in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine engraftment of donor hematopoietic stem cells, as measured by hematopoietic recovery and donor-derived hematopoiesis (determined by T cell and neutrophil specific chimerism) at 2, 3, 6, and 12 months, in patients treated with this regimen.
* Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (Hodgkin's lymphoma vs non-Hodgkin's lymphoma).
Patients receive fludarabine IV over 1 hour on days -6 to -2 and melphalan IV over 15-20 minutes on days -3 and -2. Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0. Patients receive oral tacrolimus twice daily beginning on day -3 and continuing until day 100 followed by a taper to day 180. Patients also receive methotrexate IV on days 1, 3, and 7. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study transplantation, patients are followed at 1 and 3 months, 1 year, and then annually for up to 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nonmyeloablative allogeneic stem cell transplant fludarabine phosphate 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. Nonmyeloablative allogeneic stem cell transplant allogeneic bone marrow transplantation 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. Nonmyeloablative allogeneic stem cell transplant peripheral blood stem cell transplantation 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. Nonmyeloablative allogeneic stem cell transplant melphalan 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. Nonmyeloablative allogeneic stem cell transplant methotrexate 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. Nonmyeloablative allogeneic stem cell transplant tacrolimus 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.
- Primary Outcome Measures
Name Time Method Progression-free Survival 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.
Overall Survival 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States