- HOVON 51 CML
- Included patients:
- Active sites:
A dose-ranging phase I/II study of STI571 in combination with Cytarabin in patients with first chronic phase Chronic Myeloid Leukemia.
- Prospective Phase I/II study
- Monitoring Type:
- Inclusion Criteria:
- Newly diagnosed patients with CML in first chronic phase <= 6 months;
- Presence of Philadelphia chromosome or BCR-ABL rearrangement;
- Age 18-65 years inclusive;
- WHO performance status <= 2;
- Written informed consent.
- written informed consent.
- received Imatinib maintenance as HOVON 51 protocol treatment.
- Having achieved a complete molecular response (> 4.5 log reduction by quantitative PCR), which persists for at least 2 years.
- WHO <2
- Exclusion Criteria:
- Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N);
- Renal dysfunction (creatinin >= 200 mumol/l or 2.3 mg/dl);
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix G) ;
- 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 <= 6 months;
- Unable to visit outpatient clinic at regular one-monthly intervals during the first 6 months after stopping Imatinib.
= Active hospitals
= Inactive hospitals