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

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Lymphoma, Myeloma

In brief

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.

Key facts

Study ID

NCT00943319

Run by

University of Chicago

People needed

50

Starts

2012-03-01

Expected to finish

2018-12-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase I portion:
• Relapsed or refractory acute myelogenous or lymphoid leukemia.
• Chronic myelogenous leukemia in accelerated phase or blast-crisis.
• Recurrent or refractory malignant lymphoma or Hodgkin's disease
• Recurrent or refractory multiple myeloma.
• Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
• Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
• Myelodysplastic syndromes with more than 5% blasts.
• Phase II portion:
• AML with active disease or beyond CR2.
• MDS with more than 5% blasts.

You may not qualify if…

• Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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