Newly Diagnosed High Risk B-Precursor ALL - Clofarabine

Diseases and Conditions Researched

Leukemia, not otherwise specified

What is the purpose of this trial?

1.) 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.
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 VHR-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (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).


Participation Guidelines

Age: 365 Days - 31 Years
Gender: Both

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Sponsor: Children's Oncology Group (The)
Dates:
Last Updated:
Study HIC#: 1203009873