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Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

NCT00943319 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-04

Study results available
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Summary

The purpose of this study is:

1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion.
2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.

Conditions

Interventions

DRUG

Busulfan

Daily intravenous dosing to target AVC

DRUG

Fludarabine

Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.

DRUG

Campath

All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).

PROCEDURE

Stem Cell Transplant

Infusion of bone marrow and donors(related/ unrelated).

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Andrew Artz, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00943319 on ClinicalTrials.gov