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

Primary Purpose

Graft Versus Host Disease, Leukemia, Lymphoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cyclosporine
methotrexate
allogeneic bone marrow transplantation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002456
Brief Title
Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
Official Title
Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Leukemia, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer F. Storb, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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