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

Study Overview

This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia that is likely to come back or spread.

Study Description

The purpose of this study is to determine if the administration of post-Induction age-adjusted intrathecal triple therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance (IM) high-dose methotrexate (IMHDM) backbone will improve 5-year disease-free survival (DFS) of children with high-risk (HR) B-acute lymphoblastic leukemia (ALL) compared to age-adjusted intrathecal (IT) methotrexate (MTX); and to determine, in a randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) will improve the 4-year DFS of children, adolescents, and young adults with very high-risk (VHR) B-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control Arm).

Additional Information

Participants will not be paid for their participation.

  • IRB Number: 1112007684 (PHO-COG-FALLON-AALL1131)
  • Research Study Identifier: TX6087
  • Principal Investigator: Batra Sandeep, MD

Recruitment Status


Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Registry

Create your profile and be matched to research opportunities

Register Now!

Contact Us

If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.