NCT01460160

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT01460160

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Summary

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 lymphoblastic leukemia

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL)
* Age \>1 year and \< less than 18 years old
* Induction chemotherapy ≤ 14 days according to institutional standard of care
* Adequate liver, renal and cardiac function

Exclusion Criteria:

* Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
* Extramedullary involvement of the testicles
* Active systemic bacterial, fungal or viral infection
* Down syndrome

Disease(s) and\or Condition(s)

Leukemia, Pediatric

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Dasatinib
- Description: Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
- Arm Group Labels: Arm 1: Dasatinib

Sponsor

Bristol-Myers Squibb