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


Phase 3
N/A
N/A
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Lymphoma

Thank you

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
studies

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Rainer F. Storb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

267.01

NCT ID:

NCT00002456

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109