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

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

1. To determine if the administration of post induction age adjusted intrathecal (IT) triple therapy on an MBFM-IMHDM backbone wlll improve 5 year survival when compared to IT MTX
2. 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 Very high risk ALL compared to a modified MBFM-IMHDM regimen that contains a second interim maintenance (Control Arm).
3. 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).

Protocol Number111106
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesAny Site
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.