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

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.

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).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute lymphoblastic leukemia
  • Age: Between 1 Years - 30 Years
  • Gender: Male or Female

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Be between 1 and 30 years of age
  • Have a White Blood Cell Count of:
    • Age 1-9.99 years: WBC >= 50 000/μL
    • Age 10-30.99 years: Any WBC
  • Have newly diagnosed B lymphoblastic leukemia (2008 WHO classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible

For a full list of participation criteria, please visit clinicaltrials.gov.


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX6087

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