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A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia

Phase 1/Phase 2
18 Years
Not Enrolling
Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia

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Trial Information

A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia


I. Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib
mesylate in patients with blastic phase chronic myelogenous leukemia.

II. Determine the safety of this regimen in these patients. III. Determine the
pharmacokinetics of this regimen in these patients. IV. Determine the frequency of
hematologic and cytogenetic responses, duration of response, and survival of patients
treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of cytarabine.

Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib
mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at
least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine
IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in
bone marrow on day 28 receive a second course in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are
followed monthly.

Inclusion Criteria:

- Diagnosis of chronic myelogenous leukemia in myeloid blast crisis

- At least 30% blasts in bone marrow

- Philadelphia chromosome positive by cytogenetic analysis

- bcr/abl translocation by fluorescent in situ hybridization

- Ineligible for or refused allogeneic stem cell transplantation

- Not previously treated with imatinib mesylate OR currently receiving imatinib
mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart

- Performance status - ECOG 0-2

- See Disease Characteristics

- Bilirubin less than 3 times upper limit of normal (ULN)

- AST and ALT less than 3 times ULN

- Creatinine less than 2 times ULN

- No New York Heart Association class III or IV heart disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for at least 2
weeks after study for female patients and at least 3 months after study for male

- See Disease Characteristics

- No prior allogeneic bone marrow or peripheral blood stem cell transplantation

- At least 48 hours since prior interferon alfa

- At least 24 hours since prior hydroxyurea

- At least 6 weeks since prior busulfan

- No other prior chemotherapy for blast crisis (except hydroxyurea)

- Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis

- At least 4 weeks since prior investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Toxicity according to NCI/NIH Common Toxicity Criteria

Outcome Description:

Described by duration, relatedness to treatment, and action taken.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Ronald Paquette

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California at Los Angeles (UCLA )


United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Blastic Phase Chronic Myelogenous Leukemia
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Relapsing Chronic Myelogenous Leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



University of California at Los Angeles (UCLA ) Los Angeles, California  90095