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Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant

NCT00143845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-03-08

Study results available
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Summary

The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.

Conditions

Interventions

PROCEDURE

Reduced intensity conditioning

Busulfan and Fludarabine regimen

PROCEDURE

Rapid immunosuppressive taper

Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil

PROCEDURE

Prophylactic donor leukocyte infusions

If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • John E. Levine, MD, MS · The Univeristy of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2010-11-30
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00143845 on ClinicalTrials.gov