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Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

Phase 2
12 Years
Open (Enrolling)
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia

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Trial Information

Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias

The specific aims of the project are (1) conduct the phase II study of clofarabine and
evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in
terms of complete response (CR) rate, response duration, and survival; and (2) analyze the
relationship between cellular uptake and retention of clofarabine triphosphate (the active
metabolite), inhibition of DNA synthesis, and clinical outcome.

Inclusion Criteria

- Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in
transformation (includes CML-blastic phase and CML-accelerated phase).

- No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study,
unless progressive life-threatening leukemia as judged by the treated physician.

- Adequate liver function (bilirubin mg%).

- Pregnant and lactating females not eligible.

- Zubrod performance status 0-2

- Adequate cardiac status

- No life-threatening conditions (e.g. infections) which may cause death within 3

Type of Study:


Study Design:

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

Principal Investigator

Hagop M Kantarjian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

June 2005

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • clinical
  • pharmacodynamics
  • investigational drug clofarabine
  • AML, ALL, CML-accelerated phase, CML-blastic phase
  • Chronic Myelogenous Leukemia - accelerated phase
  • Chronic Myelogenous Leukemia - blastic phase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive