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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00005803 |
Purpose
This phase I/II trial is studying how well giving autologous stem cell transplant followed by donor stem cell transplant works in treating patients with relapsed or refractory lymphoma. 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 tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect)
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Burkitt Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Prolymphocytic Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia |
Procedure: peripheral blood stem cell transplantation Drug: cyclophosphamide Radiation: total-body irradiation Drug: carmustine Drug: etoposide Drug: cytarabine Drug: melphalan Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: cyclosporine Procedure: autologous hematopoietic stem cell transplantation Biological: therapeutic autologous lymphocytes |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 1999 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (tandem transplantation)
See Detailed Description
|
Procedure: peripheral blood stem cell transplantation
Undergo allogeneic transplantation
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Radiation: total-body irradiation
Undergo radiotherapy
Other Name: TBI
Drug: carmustine
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: melphalan
Given IV
Other Names:
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo allogeneic transplantation
Drug: fludarabine phosphate
Given IV
Other Names:
Drug: mycophenolate mofetil
Given IV
Other Names:
Drug: cyclosporine
Given PO
Other Names:
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous transplantation
Biological: therapeutic autologous lymphocytes
IV donor lymphocyte infusion
Other Names:
|
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, 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 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 1, 1.5, 2, and 3 years and then annually thereafter.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: David G. Maloney 206-667-5616 | |
| Principal Investigator: David G. Maloney | |
| VA Puget Sound Health Care System | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Thomas R. Chauncey 206-762-1010 | |
| Principal Investigator: Thomas R. Chauncey | |
| Germany | |
| Universitaet Leipzig | Recruiting |
| Leipzig, Germany, D-04103 | |
| Contact: Dietger Niederwieser 0341-97-13050 | |
| Principal Investigator: Dietger Niederwieser | |
| Principal Investigator: | David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Maloney, David, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00005803 History of Changes |
| Other Study ID Numbers: | 1409.00, NCI-2010-00130, P01CA078902 |
| Study First Received: | June 2, 2000 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Federal Government |
|
Burkitt Lymphoma Hodgkin Disease Immunoblastic Lymphadenopathy Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia |
Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, B-Cell Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, Large-Cell, Anaplastic Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Mantle-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections |