Imatinib in combination with Cytarabine as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized phase III study.

Recruiting

Conditions: First chronic phase Chronic Myeloid Leukemia

Registration Number: NL-OMON21778

Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 330

Inclusion Criteria

1. Newly diagnosed patients with CML in first chronic phase <= 2 months;
2. Presence of Philadelphia chromosome or bcr-abl rearrangement;
3. Age 18-65 years inclusive;
4. WHO performance status <= 2;
5. Written informed consent.

Exclusion Criteria

1. CML in accelerated phase or blastic crisis as defined by the WHO criteria;
2. Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N, and/or ASAT >= 4 x N);
3. Renal dysfunction (creatinine >= 200 micromol/l or 2.3 mg/dl);
4. Severe cardiac dysfunction (NYHA classification II-IV);
5. Severe pulmonary or neurologic disease;
6. Pregnant or lactating females;
7. 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;
8. Patients known to be HIV-positive;
9. Patients with active, uncontrolled infections;
10. Previous treatment other than hydroxyurea <= 2 months or imatinib <= 1 month;
11. Male and female patients of reproductive potential who are not practicing effective means of contraception.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of major molecular response at 12 months from randomization.

Secondary Outcome Measures

Name	Time	Method
1. Rate and duration of major and complete molecular response;<br>2. Rate and duration of major and complete cytogenetic response;<br>3. Rate and duration of complete hematological response;<br>4. Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first);<br>5. Overall survival measured from the time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive;<br>6. Toxicity;<br>7. Actual dose-intensity of imatinib delivered;<br>8. Incidence of mutations of abl-kinase domain.