Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

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.