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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002456 |
Purpose
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against normal tissues. Methotrexate and cyclosporine may prevent this from happening.
PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Leukemia Lymphoma |
Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease |
| Study Start Date: | May 1986 |
OBJECTIVES: I. Determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (GVHD) in patients undergoing allogeneic bone marrow transplantation.
OUTLINE: Patients receive methotrexate IV on days 1,3,6, and 11. Patients also receive cyclosporine IV twice a day until the patient is eating, then it is administered orally twice a day. Cyclosporine begins on day -1 and continues until day 180. The dose is reduced beginning on day 50.
PROJECTED ACCRUAL: Accrual will continue until further notice.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Ongoing bone marrow transplantation from HLA-matched siblings or HLA non-identical family members or unrelated donor
PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not severely limited by disease other than leukemia Hematopoietic: Not specified Hepatic: No severe hepatic disease Renal: No history of hemorrhagic cystitis No renal disease Cardiovascular No symptomatic cardiac disease Other: No contraindication to the use of cyclosporine or methotrexate
PRIOR CONCURRENT THERAPY: No concurrent experimental treatment on other GVHD prophylaxis studies
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Rainer F. Storb, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000074146, FHCRC-267.01, FHCRC-267.00, NCI-V86-0145 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002456 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia childhood non-Hodgkin lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia |
recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia recurrent adult non-Hodgkin lymphoma graft versus host disease |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclosporins Leukemia Antifungal Agents Therapeutic Uses Abortifacient Agents Methotrexate |
Lymphoma Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Graft vs Host Disease Lymphoproliferative Disorders |
