Patients with first chronic phase Chronic Myeloid Leukemia. MedDRA version: 9.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia
Conditions
Interventions
Trade Name: Glivec
Pharmaceutical Form: Capsule, hard
Product Name: cytarabin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: cytarabin
CAS Number: 147-94-4
Other descriptive name: A
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Rate and duration of major and complete molecular response; Rate and duration of major and complete cytogenetic response; Rate and duration of complete hematological response; Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first); 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; Toxicity; Actual dose-intensity of imatinib delivered; Incidence of mutations of abl-kinase domain. ;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 | — |
Countries
Belgium
Outcome results
None listed