Main info

Identifier:

HOVON 51 CML

Sponsor:

HOVON

Included patients:

165

Active sites:

15

(of 16)

Title:

A dose-ranging phase I/II study of STI571 in combination with Cytarabin in patients with first chronic phase Chronic Myeloid Leukemia.

Timeline

Flow

Details

Phase:

Prospective Phase I/II study

Monitoring Type:

Objectives:

Eligibility

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.

Late randomization

• 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;

Late randomization:

• Unable to visit outpatient clinic at regular one-monthly intervals during the first 6 months after stopping Imatinib.

Participating Sites

= Active hospitals

= Inactive hospitals