(COG AALL1131) A Phase III Randomized Trial for Newly Diagnosed High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

Title (COG AALL1131) A Phase III Randomized Trial for Newly Diagnosed High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
Principal Investigator Martin Brecher, MD
Study Number 206911
Phase3
Summary To define optimal intrathecal agents for use with effective chemotherapy with minimal increase in toxicity nad/or burden of therapy for children with HR-ALL.  Patient will be randomized to post-induction therapy with a modified BFM backbone that includes a single Interim Maintenance (IM) phase with high dose methotrexate and a single Delayed Intensification (DI) phase with either intrathecal methotrexate only.
Eligibility Please see ClinicalTrials.gov link