Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Alemtuzumab; Clofarabine; Melphalan

Criteria

Inclusion Criteria:

• 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 Criteria:

• Clinical progression