Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
NCT00004255 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2013-07-10
Summary
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
Conditions
Interventions
- BIOLOGICAL
-
anti-thymocyte globulin
- BIOLOGICAL
- DRUG
- DRUG
-
fludarabine phosphate
- DRUG
-
methylprednisolone
- DRUG
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
in vitro-treated bone marrow transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
Chimeric Therapies
lead INDUSTRY
Principal Investigators
-
James N. Lowder, MD · Chimeric Therapies
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 12 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-03-31
- Completion
- 2003-05-31
Countries
- United States
Study Locations
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