This study is in progress, not accepting new patients

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

a study on Leukemia Acute Lymphoblastic Leukemia

Summary

Eligibility
for people ages 1-17 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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

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

Keywords

Leukemia, Pediatric Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Dasatinib

Eligibility

For people ages 1-17

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

Locations

  • Ucsf - Hematology/Oncology
    San Francisco California 94143-0106 United States
  • Children'S Hospital Of L.A.
    Los Angeles California 90027 United States
  • Southern California Permanente Medical Group
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County
    Orange California 92868 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT01460160
Phase
Phase 2
Study Type
Interventional
Last Updated