AN OPEN LABEL PHASE II STUDYTO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION ANDCONSOLIDATION THERAPY WITH DASATINIB IN COMBINATION WITHCHEMOTHERAPY IN PATIENTS AGED 55 YEARS AND OVER WITHPHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR-ABL+) ACUTELYMPHOBLASTIC LEUKEMIA (ALL). - ND
- Conditions
- Philadelphia chromosome positive acute lymphoblasticleukaemiaMedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLTClassification code 10024290Term: Leukaemias acute lymphocytic
- Registration Number
- EUCTR2006-005694-21-IT
- Lead Sponsor
- HOPITAL MIGNOT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 (three doses cyclophosphamide
accepted but not recommended)
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) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
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: Primary objective:<br>To evaluate the efficacy of a dasatinib based induction and<br>consolidation therapy.;Secondary Objective: Secondary objective:<br>To evaluate the safety of a dasatinib based induction and<br>consolidation therapy;Primary end point(s): 1. Primary endpoint:<br>Progression free survival at 12 months<br>2. Secondary endpoints :<br>a. The proportion of Complete haematological<br>remission<br>b. The proportion of Major molecular response<br>defined by a BCR-ABL/ABL ≤ 0.1% in bone<br>marrow<br>c. The proportion of Complete molecular response<br>d. Event free survival<br>e. Relapse free survival<br>f. Progression free survival<br>g. The proportion of Detection of a T315I or F317<br>BCR-ABL TK mutation<br>h. The proportion of Molecular progression<br>i. Overall survival<br>j. Tolerance
- Secondary Outcome Measures
Name Time Method