Status:
COMPLETED
Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Lead Sponsor:
University of Chicago
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00943319
Start Date
March 1 2012
End Date
December 1 2018
Last Update
February 4 2019
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637