Completed

Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease

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What is being tested

cyclosporine

+ methotrexate

+ allogeneic bone marrow transplantation

DrugProcedure
Who is being recruted

Chronic Disease+19

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 3
Interventional
Study Start: May 1986
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: November 30, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1986

Actual date on which the first participant was enrolled.

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.

NCT00002456
Principal SponsorFred Hutchinson Cancer Center
Last updated: November 30, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellDisease AttributesGraft vs Host DiseaseLeukemiaLymphomaLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fred Hutchinson Cancer Research Center

Seattle, United StatesOpen Fred Hutchinson Cancer Research Center in Google Maps
CompletedOne Study Center