- HOVON 78 CML
- Included patients:
- Active sites:
Imatinib in combination with Cytarabin as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized study.
- Prospective randomized Phase III study
- Monitoring Type:
To determine the efficacy of the combination of imatinib with cytarabine as compared to imatinib alone in terms of the rate of molecular response at 12 months from randomization.
- Inclusion Criteria:
- Newly diagnosed patients with CML in first chronic phase ? 2 months;
- Presence of Philadelphia chromosome or bcr-abl rearrangement;
- Age 18-65 years inclusive;
- WHO performance status ? 2 (see appendix E);
- Written informed consent.
- Exclusion Criteria:
- CML in accelerated phase or blastic crisis as defined by the WHO criteria (see appendix A).
- Hepatic dysfunction (serum bilirubin ? 2 x N, and/or ALAT ? 4 x N, and/or ASAT ? 4 x N);
- Renal dysfunction (creatinine ? 200 ?mol/l or 2.3 mg/dl);
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix F);
- Severe pulmonary or neurologic disease;
- Pregnant or lactating females;
- Patients with a history of active malignancy during the past 5 years with the exception of
basal carcinoma of the skin or stage 0 cervical carcinoma;
- Patients known to be HIV-positive;
- Patients with active, uncontrolled infections;
- Previous treatment other than hydroxyurea ? 2 months or imatinib ? 1 month;
- Male and female patients of reproductive potential who are not practicing effective means of