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A Study to Determine the Safety and Efficacy of STI571 in Patients With Chronic Myeloid Leukemia Who Are Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha, or Intolerant of, Interferon-Alpha


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Study to Determine the Safety and Efficacy of STI571 in Patients With Chronic Myeloid Leukemia Who Are Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha, or Intolerant of, Interferon-Alpha


OBJECTIVES: I. Evaluate the safety profile of STI571 in patients with Philadelphia
chromosome positive (or chromosome negative and Bcr/Abl positive) chronic phase chronic
myelogenous leukemia who are refractory to or intolerant of interferon alfa. II. Provide
expanded access of this treatment to these patients. III. Confirm the rate of complete and
major cytogenetic response in patients treated with this regimen, as demonstrated by a
decrease in the percentage of Philadelphia chromosome positive cells in the bone marrow. IV.
Evaluate the improvement of symptomatic parameters in patients treated with this regimen.

OUTLINE: This is an expanded access, multicenter study. Patients receive oral STI571 daily.
Treatment continues for 12 months in the absence of disease progression or unacceptable
toxicity. Patients who respond after 12 months may continue with therapy.

PROJECTED ACCRUAL: Not determined

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myelogenous leukemia (CML)
Philadelphia (Ph) chromosome positive OR Bcr/Abl positive Refractory to or intolerant of
interferon alfa therapy Failure to achieve complete response for at least 1 month after at
least 6 months of interferon alfa therapy OR At least 65% Ph chromosome positivity in bone
marrow after at least 1 year of interferon alfa therapy OR At least 30% increase in Ph
chromosome positive bone marrow cells in samples taken at least 1 month apart or increase
to at least 65% while receiving interferon alfa therapy OR At least 100% increase in WBC
count to at least 20,000/mm3 in samples taken at least 2 weeks apart while receiving
interferon alfa therapy OR At least grade 3 nonhematologic toxicity persisting for more
than 2 weeks while receiving interferon alfa therapy (must be more than 3 months from time
of diagnosis) No greater than 15% blasts or basophils in peripheral blood or bone marrow
Less than 30% blasts plus promyelocytes in peripheral blood or bone marrow

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin no
greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN
Renal: Creatinine no greater than 2 times ULN Cardiovascular: No New York Heart
Association class III or IV heart 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 at least 3 months after study for men No history
of noncompliance to prior medical regimens

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 14 days
since prior interferon alfa No other concurrent biologic therapy Chemotherapy: At least 6
weeks since prior busulfan At least 14 days since prior cytarabine At least 7 days since
prior hydroxyurea No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified Other: At least 28 days since prior
investigational agents No other concurrent 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:

CDR0000068088

NCT ID:

NCT00006053

Start Date:

June 2000

Completion Date:

March 2003

Related Keywords:

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

Name

Location

Novartis Pharmaceuticals CorporationEast Hanover, New Jersey  07936