Clinical Trial COGAALL1131

Title

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(s)

Haydar Frangoul

Details

  • Protocol No. COGAALL1131
  • Open Date: 04/05/2012
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: - To determine if the administration of post-Induction age adjusted ITT on an MBFM-IMHDM backbone will improve 5-year DFS of children with HR-ALL compared to age adjusted IT MTX. - To determine, in a randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) or the clofarabine + cyclophosphamide + etoposide combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control Arm). - To determine, in a randomized fashion, if the cyclophosphamide + etoposide + clofarabine containing combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to the cyclophosphamide + etoposide combination regimen (Experimental Arm 1).
  • Disease Sites: Leukemia; Pediatric Leukemia
  • Therapies: Chemotherapy - cytotoxic; Radiotherapy; Therapy (NOS)
  • Drugs: 6-thioguanine (6-TG); Clofarabine; Cyclophosphamide (CTX); Cytarabine (ARA-C); Dexamethasone; Dosorubicin; Doxorubicin; Etoposide; G-CSF; Hydrocortisone; Levoleucovorin; Mercaptopurine; Methotrexate; Pegaspargase (Oncaspar); Prednisone; Vincristine
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01406756
  • Secondary Protocol No: Not Specified

Description

Eligibility

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