Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Leukemia
NCT ID: NCT01460160
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:
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
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Brigham and Women's Hospital
Overall PI:
Lewis Silverman, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Eligibility Criteria
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