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Eligibility
for people ages 1 year to 17 years
Location
at San Francisco, California and other locations
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 Dasatinib

Eligibility

For people ages 1 year to 17 years

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

  • Kaiser Medical Center
    Roseville, California, 95661, USA
  • Antranik Agop Bedros
    Loma Linda, California, 92350, USA
  • Miller Children'S Hospital Long Beach
    Long Beach, California, 90806, USA
  • Children'S Hospital Of L.A.
    Los Angeles, California, 90027, USA
  • Southern California Permanente Medical Group
    Los Angeles, California, 90027, USA
  • Valley Children'S Hospital
    Madera, California, 93636, USA
  • Childrens Hospital Of Orange County
    Orange, California, 92868, USA
  • Lpch & Sumc
    Palo Alto, California, 940304, USA

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 educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
ID
NCT01460160
Phase
Phase 2
Study Type
Interventional
Last Updated
September 2016