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

The University of Chicago

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Hematologic Malignancies

Leukemia

Preleukemia

Treatments

Drug: Clofarabine

Procedure: Stem Cell Transplant

Drug: Campath

Drug: Melphalan

Study type

Interventional

Funder types

Other

Identifiers

NCT00943592

14341B

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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