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. - HOVON 78 CM
- Conditions
- Patients with first chronic phase Chronic Myeloid Leukemia.MedDRA version: 9.1Level: LLTClassification code 10052065Term: Chronic phase chronic myeloid leukaemia
- Registration Number
- EUCTR2005-003839-41-BE
- Lead Sponsor
- HOVON Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 mmol/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 contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Rate and duration of major and complete molecular response;<br>Rate and duration of major and complete cytogenetic response;<br>Rate and duration of complete hematological response;<br>Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first);<br>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>Toxicity;<br>Actual dose-intensity of imatinib delivered;<br>Incidence of mutations of abl-kinase domain.<br>;Main Objective: 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.;Primary end point(s): Rate of major molecular response at 12 months from randomization
- Secondary Outcome Measures
Name Time Method