Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C
Condition: Myelogenous Leukemia, Chronic, Chronic Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Gleevec
Intervention description: 400 mg orally twice daily
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Philadelphia chromosome positive; early chronic phase (diagnosis < 12 months); Chronic Myelogenous Leukemia, Chronic Phase; Chronic Myelogenous Leukemia; CML; Gleevec; STI571

Summary:

      The goal of this clinical research study is to see if higher doses of imatinib mesylate
      (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients age 15 years or older with a diagnosis of Ph-positive or Bcr-positive CML in
             early chronic phase CML (diagnosis < 12 months). Except for hydroxyurea, patients must
             have received no or minimal prior therapy, defined as less than 1 month of prior
             interferon (IFN-a) or ara-C.

          2. Eastern Cooperative Oncology Group (ECOG) performance of 0-2

          3. Serum bilirubin less than 2 mg%, serum creatinine less than 2mg%

          4. Women of pregnancy potential must practice contraception. Women and men must continue
             birth control for the duration of the trial and at least 3 months after the last dose
             of study drug.

          5. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

          6. The definitions of CML phases are as follows: a) early chronic phase: time from
             diagnosis to therapy < 12 months, late chronic phase: time from diagnosis to therapy >
             12 months; b) blastic phase: presence of 30% blasts or more in the peripheral blood or
             bone marrow; c) accelerated phase CML: presence of any of the following features:
             peripheral or marrow blasts 15% or more, peripheral or marrow basophils 20% or more,
             thrombocytopenia <100 x 10(9)/L unrelated to therapy, documented extramedullary
             blastic disease outside liver or spleen due to past causes

          7. The definitions of CML phases are as follows: clonal evolution defined as the presence
             of additional chromosomal abnormalities other than the Ph chromosome is part of
             accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations
             are not considered to indicate disease acceleration. We have recently found clonal
             evolution to have a variable prognostic impact and may be suppressed with IFN-a
             therapy. Hence these patients will be eligible if no other accelerated phase signs are
             present, and analyzed separately.

          8. Inclusion of women and minorities: As per NIH policy, women and members of minorities
             will be included in this protocol as they are referred in the CML population. Their
             distribution is similar to the general referral profiles for CML: about 50% of CML
             patients are females and 25% to 30% are members of minorities. There are no exclusions
             of women or minorities based on the study objectives.

        Exclusion Criteria:

          1. New York Heart Association (NYHA) class 3-4 heart disease

          2. Psychiatric disability (psychosis)

          3. Pregnant or lactating females

          4. Patients in late chronic phase, accelerated phase or blastic phase are excluded.