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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006747 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Lymphoma |
Biological: sargramostim Biological: therapeutic allogeneic lymphocytes Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: methotrexate Drug: tacrolimus Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Allogeneic Stem Cell Transplantation for Mantle Cell Lymphoma |
| Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover.
Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists.
Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3.5 years.
Eligibility| Ages Eligible for Study: | up to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma of any stage with at least 1 of the following:
Bone marrow biopsy required
First remission allowed if at least 1 of the following poor prognostic characteristics present:
International Prognostic Index (IPI) score higher than 1 defined by the following risk factors:
Failure of initial therapy with anthracycline-containing regimen allowed
HLA matched (6/6) sibling donor by serologic typing (A, B, or DR)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 48 Study Locations| Study Chair: | Koen Van Besien, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000068324, CLB-59908 |
| Study First Received: | December 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006747 History of Changes |
| Health Authority: | United States: Federal Government |
|
graft versus host disease stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
|
Antimetabolites Anti-Infective Agents Melphalan Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Reproductive Control Agents Tacrolimus Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Lymphoma Etoposide Alkylating Agents Nucleic Acid Synthesis Inhibitors Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Carmustine Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Antiviral Agents Pharmacologic Actions |