S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
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|ClinicalTrials.gov Identifier: NCT00121186|
Recruitment Status : Terminated (poor accrual)
First Posted : July 21, 2005
Results First Posted : April 3, 2012
Last Update Posted : April 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||December 2011|
Experimental: 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.
Drug: fludarabine phosphate
30 mg/m^2 on days -6 to -2 (2-6 days before transplant).
70 mg/m^2 on days -3 and -2 (2-3 days before transplant).
5 mg/m^2 on days 1, 3, and 7 post-transplant.
0.03 mg/kg bid on days -3 to 100 post-transplant.
Procedure: allogeneic bone marrow transplantation
if donor bone marrow stem cells are harvested
Procedure: peripheral blood stem cell transplantation
if donor peripheral blood stem cells are harvested
- Progression-free Survival [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121186
|Study Chair:||Patrick J. Stiff, MD||Loyola University|
|Study Chair:||Scott E. Smith, MD, PhD, FACP||Loyola University|