Philadelphia chromosome positive Acute Lymphoblastic Leukemia
Conditions
Interventions
Sponsors
CH-Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 55 years 2. Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia 3. Not previously treated except with corticosteroids (or single dose vincristine) 4. With or without documented CNS involvement 5. Signed written inform consent 6. Molecular evaluation for BCR-ABL done Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with ECOG status > 2 2. Patient previously treated with Tyrosine Kinase Inhibitors 3. Patients with QTc > 450 ms 4. Heart insufficiency NYHA grade III/IV, LEVF 2,5 times the institutional upper limit of normal and total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia 10. Concurrent severe diseases which exclude the administration of therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a dasatinib-based induction and consolidation therapy;Secondary Objective: To evaluate the tolerability of a dasatinib based induction and consolidation therapy;Primary end point(s): The primary end point will be Progression Free Surival (PFS) rate at 12 months: PFS is defined as the time from the date of first therapy until the time of haematological relapse. Subjects who die without a reported progression will be considered to have progressed on the date of their death. Subject who do not progress nor die will be censored on the date of their last haematological assessment | — |
Countries
Belgium, France, Germany, Italy
Outcome results
None listed