Phase II Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Conditions: EUKEMIA, PEDIATRIC
MedDRA version: 16.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001123-20-Outside-EU/EEA

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 90

Inclusion Criteria

- Newly diagnosed Philadelphia chromosome positive ALL
- Age>1 year and < less than 18 years old
- Induction chemotherapy - Adequate liver, renal and cardiac function
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
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<br>- Event Free Survival rate<br>- Minimal Residual Disease levels<br>- Complete Remission rates<br>- Estimate BCR-ABL mutation status;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<br>- Event free survival rate<br>- Minimal Residual Disease levels<br>- Complete Remission Rates compared with AIEOP BFM 2000 and the Amended EsPhALL trials<br>- Estimate BCR-ABL mutation status;Timepoint(s) of evaluation of this end point: - Continuously<br>- Three and 5 years following the 75th patient's first visit<br>- At screening, treatment blocks 1B, HR1, HR3, End of treatment, 6 and 12 months post transplant, at progression<br>- End of Induction and Consolidation therapy<br>- Baseline and time of disease progression or relapse