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Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Advanced Hematologic Malignancies, Leukemia, Preleukemia

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Trial Information

Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of conditioning regimen prior to stem cell transplantation.

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Andrew Artz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

November 2013

Related Keywords:

  • Advanced Hematologic Malignancies
  • Leukemia
  • Preleukemia
  • Melphalan
  • Alemtuzumab
  • Clofarabine
  • Neoplasms
  • Leukemia
  • Preleukemia
  • Myelodysplastic Syndromes
  • Hematologic Neoplasms



The University of Chicago Chicago, Illinois  60637