test

Newly Diagnosed High Risk B-Precursor ALL - Clofarabine

Conditions

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

Click here for detailed information about who can participate in this trial.


Sponsor:
Children's Oncology Group (The)
Dates:
04/11/2012
Last Updated:
Study HIC#:
1203009873