Status:
COMPLETED
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Lead Sponsor:
University of Chicago
Conditions:
Advanced Hematologic Malignancies
Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood...
Eligibility Criteria
Inclusion
- Relapsed or refractory acute myelogenous or lymphoid leukemia
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in second or subsequent chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma at high risk for disease recurrence
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
- Myelodysplastic syndromes (including PNH) with \> 5% blasts
- Zubroid performance status \< 2 (See Appendix B)
- Life expectancy is not severely limited by concomitant illness
- Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
- Calculated Creatinine Clearance \> 50 ml/min
- Serum bilirubin 2.0 mg/dl, SGPT \< 3x upper limit of normal
- No evidence of chronic active hepatitis or cirrhosis
- HIV-negative
- Patient is not pregnant
- Patient or guardian able to sign informed consent
Exclusion
- Clinical progression
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00943592
Start Date
March 1 2006
End Date
November 1 2013
Last Update
February 27 2014
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637