Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Leukemia, Pediatric

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT01460160

CA180-372

2011-001123-20 (EudraCT Number)

AALL1122 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Arm 1: Dasatinib

Experimental group

Treatment:

Drug: Dasatinib