Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Completed · Phase 1/Phase 2
Conditions studied: Advanced Hematologic Malignancies, Leukemia, Preleukemia
In brief
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 cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
Key facts
- Study ID
- NCT00943592
- Run by
- University of Chicago
- People needed
- 82
- Starts
- 2006-03-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-02-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Clinical progression
Where it is running
- The University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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