Clinical Studies Search

Protocol Summary


Protocol No.
PSHCI-12-012
Prinicipal Investigator
McGregor, Lisa
Phase
Phase III
Age Group
Both
Scope
National
Secondary Protocol No.
AALL1131
Title
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-Like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
Objective
Primary:
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).
Applicable Disease Sites
Leukemia, other
Status
Open
Participating Institutions
Hershey Medical Center
Contact
Name
[unknown] COG Contact
Phone No.
+1 717-531-6012