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A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase


OBJECTIVES: I. Determine the safety of STI571 in patients with accelerated phase
Philadelphia chromosome positive (or chromosome negative and Bcr/Abl positive) chronic
myelogenous leukemia. II. Determine the rate of hematological response to this treatment in
these patients. III. Determine the improvements in symptomatic parameters with this
treatment in these patients. IV. Determine the cytogenetic response to this treatment in
these patients. V. Determine the time to treatment failure in these patients after receiving
this treatment.

OUTLINE: Patients receive oral STI571 daily. Treatment continues for at least 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: Confirmed diagnosis of chronic myelogenous leukemia in
accelerated phase At least 15% but less than 30% blasts in blood or bone marrow At least
30% blasts plus promyelocytes in the peripheral blood or bone marrow At least 20%
peripheral basophils Thrombocyte count less than 100,000/mm3 (unrelated to therapy)
Patients must have never been in blastic phase Ph chromosome positive OR Ph chromosome
negative and Bcr/Abl positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Blood counts recovered from any
prior antileukemic agents Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) (no greater than 3 times ULN if liver involvement suspected) AST and ALT no
greater than 3 times ULN (no greater than 5 times ULN if liver involvement suspected)
Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac
disease Other: No serious other concurrent medical condition 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 with medical regimens

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa
Prior hematopoietic stem cell transplantation allowed if blood counts have recovered No
concurrent biologic therapy Chemotherapy: At least 14 days since prior homoharringtonine
At least 24 hours since prior hydroxyurea At least 7 days since prior low dose cytarabine
(less than 30 mg/m2 every 12-24 hours daily) At least 14 days since prior moderate dose
cytarabine (100-200 mg/m2 for 5-7 days) At least 28 days since prior high dose cytarabine
(1-3 g/m2 every 12-24 hours for 6-12 doses) At least 21 days since prior anthracyclines,
mitoxantrone, etoposide, methotrexate, or cyclophosphamide At least 6 weeks since prior
busulfan No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not
specified Surgery: Not specified Other: At least 28 days since prior other investigational
agents No concurrent other 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:

CDR0000068087

NCT ID:

NCT00006052

Start Date:

June 2000

Completion Date:

Related Keywords:

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

Name

Location

Novartis Pharmaceuticals CorporationEast Hanover, New Jersey  07936