AN OPEN LABEL PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND CONSOLIDATION THERAPY WITH DASATINIB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS AGED 55 YEARS AND OVER WITH PHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR-ABL+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL).EWALL-PH-01 - EWA
- Conditions
- Philadelphia chromosome positive Acute Lymphoblastic Leukemia
- Registration Number
- EUCTR2006-005694-21-FR
- Lead Sponsor
- CH-Versailles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
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
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 < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study
5. Active secondary malignancy
6. Patients with active bacterial, viral or fungal infection
7. Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
8. Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
9. Inadequate hepatic functions defined as ASAT or ALAT > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br><br>PFS is defined as the time from the date of first therapy until the time of haematological relapse.<br>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
- Secondary Outcome Measures
Name Time Method