This trial is active, not recruiting.

Conditions leukemia, lymphoma, myeloma
Treatments busulfan, fludarabine, campath, stem cell transplant
Phase phase 1/phase 2
Target CD52
Sponsor University of Chicago
Start date March 2012
End date March 2017
Trial size 124 participants
Trial identifier NCT00943319, 12-0132


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame: 5 years

Secondary Outcomes

Evaluate disease free and overall survival
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 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 Criteria: - 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.

Additional Information

Official title A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Principal investigator Andrew Artz, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chicago.