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

No results posted yet for this study

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

filgrastim

DRUG

fludarabine phosphate

DRUG

methylprednisolone

DRUG

tacrolimus

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004255 on ClinicalTrials.gov