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Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

This study has been completed.
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: November 1, 1999
Last updated: November 28, 2011
Last verified: November 2011

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 3

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: May 1986
Study Completion Date: April 2002
Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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Please refer to this study by its identifier: NCT00002456

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Study Chair: Rainer F. Storb, MD Fred Hutchinson Cancer Research Center
  More Information Identifier: NCT00002456     History of Changes
Other Study ID Numbers: 267.01
CDR0000074146 ( Registry Identifier: PDQ )
Study First Received: November 1, 1999
Last Updated: November 28, 2011

Keywords provided by Fred Hutchinson Cancer Research Center:
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

Additional relevant MeSH terms:
Graft vs Host Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors processed this record on August 18, 2017