Phase II Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
- Conditions
- EUKEMIA, PEDIATRICTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2011-001123-20-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Newly diagnosed Philadelphia chromosome positive ALL - Age>1 year and < less than 18 years old - Induction chemotherapy Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
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
- Prior treatment with BCR-ABL inhibitor - Extrameduallary involvement of the testicles - Active systemic bacterial, fungal or viral infection - Down syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblatic leukemia;Secondary Objective: - Safety and feasibility of dasatinib added to standard chemotherapy - Event Free Survival rate - Minimal Residual Disease levels - Complete Remission rates;Primary end point(s): Event free survival rate at 3 years of dasatinib plus chemotherapy compared with external historical controls;Timepoint(s) of evaluation of this end point: Three years following the 75th patient's first visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Safety and feasibility of dasatinib added to standard chemotherapy - Event free survival rate - Minimal Residual Disease levels - Complete Remission Rates;Timepoint(s) of evaluation of this end point: - Continuously - Three and 5 years following the 75th patient's first visit - At screening, treatment blocks 1B, HR1, HR3, End of treatment, 6 and 12 months post transplant, at progression - End of Induction and Consolidation therap