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

Phase 3
Not Enrolling
Graft Versus Host Disease, Leukemia, Lymphoma

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Rainer F. Storb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

May 1986

Completion Date:

April 2002

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • 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
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma



Fred Hutchinson Cancer Research Center Seattle, Washington  98109