Clinical Trial VICCPED1186
Title
CA180-372 / AALL1122 - A Phase 2 Multi-Center, Historically-Controlled Study of Dasatinib (IND# 66, 971) Added to Standard Chemotherapy in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
Principal Investigator(s)
Details
- Protocol No. VICCPED1186
- Open Date: 06/11/2012
- Staging: Phase II
- Age Group: Both Child and Adult
- Scope: National
- Objective: Compare the 3-year event-free survival (EFS) with the external historical controls of the AIEOP-BFM 2000 and EsPhALL trials.
- Disease Sites: Pediatrics; Leukemia; Pediatric Leukemia
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: 6-mercaptopurine (6-MP); 6-thioguanine (6-TG); Cyclophosphamide (CTX); Cytarabine (ARA-C); Dasatinib (BMS-354825); Daunorubicin (Daunomycin); Dexamethasone; Ifosfamide; L-Asparaginase; Leucovorin (Folinic acid); Methotrexate; Vincristine
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01460160
- Secondary Protocol No: CA180372
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 1 Year to 17 Years |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Learn More
- Call toll-free number: 1-800-811-8480
- Use our Online self–referral form
- Print this page for your doctor
You do not have JavaScript enabled. This site works better with JavaScript turned on.
