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An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis


OBJECTIVES: I. Determine the safety profile of STI571 in patients with chronic myelogenous
leukemia in blast crisis. II. Provide expanded access of this treatment to these patients.
III. Determine the rate of hematological response and duration of response in patients
treated with this regimen. IV. Determine the improvements in symptomatic parameters in
patients treated with this regimen. V. Determine the cytogenetic response in patients
treated with this regimen. VI. Determine the overall survival in patients treated with this
regimen.

OUTLINE: This is an expanded-access, multicenter study. Patients receive oral STI571 daily.
Treatment continues for 1 year in the absence of disease progression or unacceptable
toxicity. Patients who are considered to have benefited may continue treatment beyond 1
year.

PROJECTED ACCRUAL: Not determined

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) in blast crisis,
defined by at least one of the following: 30% blasts in peripheral blood and/or bone
marrow Flow cytometry criteria Extramedullary disease other than spleen, lymph node,
and/or liver involvement Newly diagnosed CML in blast crisis OR CML in blast crisis with
prior therapy for accelerated or blastic phases Philadelphia (Ph) chromosome positive OR
Ph chromosome negative and Bcr/Abl positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT and SGPT no greater
than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
involvement) Bilirubin no greater than 3 times ULN Renal: Creatinine no greater than 2
times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective barrier contraception during
and for at least 2 weeks after study for women and for at least 3 months after study for
men No history of noncompliance with medical regimens No serious concurrent medical
condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa
At least 6 weeks since prior hematopoietic stem cell transplantation No concurrent
anticancer biologic therapy Chemotherapy: At least 6 weeks since prior busulfan At least
24 hours since prior hydroxyurea At least 2 weeks since prior homoharringtonine At least 1
week since prior low-dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least
2 weeks since prior moderate-dose cytarabine (100-200 mg/m2 for 5-7 days) At least 4 weeks
since prior high-dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 3
weeks since prior anthracyclines, mitoxantrone, or etoposide No concurrent anticancer
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified Other: At least 4 weeks since other prior investigational agents No other
concurrent anticancer investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ilana Monteleone

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068302

NCT ID:

NCT00006475

Start Date:

September 2000

Completion Date:

December 2002

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Novartis Pharmaceuticals CorporationEast Hanover, New Jersey  07936