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.
- Conditions
- Chronic myeloid leukemiaCancer
- Registration Number
- ISRCTN51564734
- Lead Sponsor
- Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase 2. Presence of Philadelphia chromosome or bcr-abl rearrangement
3. Age 18-65 years inclusive
4. World Health Organization (WHO) performance status 5. Written informed consent
1. CML in accelerated phase or blastic crisis as defined by the WHO criteria
2. Hepatic dysfunction (serum bilirubin >/= 2 x upper limit of normal [ULN], and/or alanine aminotransferase [ALAT] >/= 4 x ULN, and/or aspartate aminotransferase [ASAT >/= 4 x ULN)
3. Renal dysfunction (creatinine >/= 200 µmol/l or 2.3 mg/dl)
4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II-IV)
5. Severe pulmonary or neurological 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 human immunodeficiency virus (HIV)-positive
9. Patients with active, uncontrolled infections
10. Previous treatment other than hydroxyurea for 11. Male and female patients of reproductive potential who are not practicing effective means of contraceptio
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