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A Phase I Study of STI571 in Ph+ Leukemia

Phase 1
21 Years
Open (Enrolling)

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Trial Information

A Phase I Study of STI571 in Ph+ Leukemia


- Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in
patients with recurrent Philadelphia chromosome-positive leukemia.

- Characterize the pharmacokinetic behavior of this drug in this patient population.

- Determine preliminarily the antileukemic activity of this drug in these patients.

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

Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues
in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


- Recurrent Philadelphia (Ph) chromosome-positive leukemia

- Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR

- Chronic myelogenous leukemia with resistance to interferon alfa with any of the

- WBC at least 20,000/mm^3 after at least 3 months of interferon therapy

- At least 100% increase in WBC to at least 20,000/mm^3 confirmed over 2
weeks while receiving interferon alfa

- At least 66% Ph chromosome-positive cells after 1 year of interferon

- At least 30% increase in number of Ph chromosome-positive cells after an
interferon-induced response while continuing interferon therapy



- Under 22

Performance status:

- Karnofsky 50-100% if over 10 years of age OR

- Lansky 50-100% if 10 years of age and under

Life expectancy:

- At least 8 weeks


- See Disease Characteristics


- Bilirubin no greater than 1.5 times normal

- SGPT less than 3 times normal

- Albumin greater than 2 g/dL


- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host

- No seizure disorder if on anticonvulsants

- No uncontrolled infection

- No CNS toxicity greater than grade 2


Biologic therapy:

- See Disease Characteristics

- At least 1 week since prior biologic therapy and recovered

- At least 3 months since prior stem cell transplantation (SCT)

- At least 1 week since prior growth factors

- At least 1 week since prior interferon alfa


- Recovered from prior chemotherapy

- At least 6 weeks since prior busulfan and nitrosoureas

- At least 2 weeks since prior homoharringtonine

- At least 1 week since low-dose cytarabine

- At least 2 weeks since prior moderate-dose cytarabine

- At least 4 weeks since prior high-dose cytarabine

- At least 3 weeks since all other prior cytotoxic chemotherapies

- No prior hydroxyurea

Endocrine therapy:

- Must be on a stable dose of steroids if received prior allogeneic SCT


- Recovered from prior radiotherapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 6 months since prior craniospinal radiotherapy

- At least 6 months since prior radiotherapy to 50% or more of the pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy


- Not specified


- No other concurrent investigational agents

- No concurrent anticonvulsants

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin Champagne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Sainte Justine


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • childhood chronic myelogenous leukemia
  • Leukemia



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