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

Research Study: Investigating Combination Chemotherapy for High-Risk Acute Lymphoblastic Leukemia

Recruiting
1 years - 30 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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).

Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: acute lymphoblastic leukemia
  • Age: 1 years - 30 years
  • Gender: All

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.

Updated on 19 Feb 2024. Study ID: 1112007684 (PHO-COG-FALLON-AALL1131)

This study investigates how well combination chemotherapy works in treating young patients with acute lymphoblastic leukemia (ALL), a type of cancer that affects the blood and bone marrow and is likely to return or spread. The purpose is to see if a specific treatment approach can improve disease-free survival in children with high-risk B-ALL compared to another treatment method.

Participants will receive different chemotherapy regimens to compare their effectiveness. Some will receive a combination including cyclophosphamide and etoposide, while others will follow a modified regimen with high-dose methotrexate. These treatments aim to find out which approach provides better outcomes for patients.

  • Who can participate: Eligible participants are those aged 1 to 30 years with newly diagnosed B lymphoblastic leukemia. Children with Down syndrome are also eligible. Specific white blood cell count criteria apply: for children under 10, WBC must be less than 50,000/μL; for those 10 and older, WBC must be less than 100,000/μL.
  • Study details: Participants will be randomly assigned to receive one of two chemotherapy regimens. One group will receive a combination of cyclophosphamide and etoposide, while the other will follow a modified regimen.

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