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A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial
This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
PRIMARY OBJECTIVES: I. To evaluate engraftment of human leukocyte antibody (HLA) identical peripheral blood stem cell (PBSC) allografts given after conditioning with total-body irradiation (TBI) (200cGy) +/- fludarabine (fludarabine phosphate), 90 mg/m\^2 and post-grafting immunosuppression with cyclosporine (CSP)/mycophenolate mofetil (MMF) in refractory or relapsed lymphoma patients following an initial autologous peripheral blood stem cell transplant (PBSCT) for disease cytoreduction. II. To determine the non-relapse mortality at day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting. SECONDARY OBJECTIVES: I. To determine the disease free survival and overall survival of non-myeloablative allografting following autologous PBSCT. OUTLINE: CONDITIONING REGIMEN: Patients with matched, related stem cell donors receive cyclophosphamide intravenously (IV) on days -6 and -5 and undergo TBI twice daily (BID) on days -3 to -1. Patients with matched, unrelated stem cell donors receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours BID on days -6 to -3, and cytarabine IV over 3 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. TRANSPLANTATION: All patients undergo autologous PBSCT on day 0. NON-MYELOABLATIVE CONDITIONING: Beginning 40-120 days following PBSC transplant, patients with related donors undergo TBI on day 0. Patients with unrelated donors receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: Patients undergo non-myeloablative allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) BID on days -3 to 56 (patients with related donors) or 100 (patients with unrelated donors) followed by taper to day 180. Patients also receive mycophenolate mofetil PO BID on days 0-27 (patients with related donors) or thrice daily (TID) on days 0-27, then BID on days 28-40 followed by taper to day 96 (patients with unrelated donors). Some patients may undergo donor lymphocyte infusion if there is evidence of disease progression and no evidence of graft-vs-host disease (GVHD). After completion of study treatment, patients are followed up at day 180, 1 year, 1.5 years, 2 years, 3 years, and then annually thereafter.
Age
0 - 75 years
Sex
ALL
Healthy Volunteers
No
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Universitaet Leipzig
Leipzig, Germany
Start Date
September 1, 1999
Primary Completion Date
January 1, 2016
Completion Date
October 1, 2018
Last Updated
January 29, 2020
76
ACTUAL participants
Autologous Hematopoietic Stem Cell Transplantation
PROCEDURE
Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
PROCEDURE
Carmustine
DRUG
Cyclophosphamide
DRUG
Cyclosporine
DRUG
Cytarabine
DRUG
Etoposide
DRUG
Fludarabine Phosphate
DRUG
Laboratory Biomarker Analysis
OTHER
Melphalan
DRUG
Mycophenolate Mofetil
DRUG
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
Peripheral Blood Stem Cell Transplantation
PROCEDURE
Therapeutic Autologous Lymphocytes
BIOLOGICAL
Total-Body Irradiation
RADIATION
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT04195633
NCT07356245
Data Source & Attribution
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