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A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia


- Determine the maximum tolerated dose of daunorubicin when combined with imatinib
mesylate, vincristine, and prednisone in patients with lymphoid blastic phase chronic
myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

- Determine the safety of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the frequency of hematologic and cytogenetic responses in patients treated
with this regimen.

- Determine the duration of response of this patient population treated with this

- Determine the survival of patients treated with this regimen.

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

Patients who have not previously received imatinib mesylate receive oral imatinib mesylate
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 daunorubicin IV over 2-3
minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral
prednisone on days 1-28. 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 daunorubicin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study.

Inclusion Criteria


- One of the following diagnoses:

- Chronic myelogenous leukemia in lymphoid blast crisis

- Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction

- No more than 1 prior course of induction chemotherapy

- Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl
translocation by fluorescent in situ hybridization

- At least 30% blasts in bone marrow

- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- See Disease Characteristics


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

- ALT and AST less than 3 times ULN


- Creatinine less than 2 times ULN


- No New York Heart Association class III or IV cardiac 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


Biologic therapy:

- See Disease Characteristics

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

- At least 48 hours since prior interferon alfa


- See Disease Characteristics

- At least 24 hours since prior hydroxyurea

- At least 6 weeks since prior busulfan

- Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis

Endocrine therapy:

- Not specified


- Not specified


- Not specified


- No prior therapy for blast crisis except hydroxyurea

- No prior salvage or reinduction therapy for Ph+ ALL

- At least 4 weeks since other prior investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald Paquette, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

October 2003

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Stanford University Medical Center Stanford, California  94305-5408
City of Hope Comprehensive Cancer Center Duarte, California  91010
Oregon Cancer Institute Portland, Oregon  97201-3098