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International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Study on Investigational Approaches for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Recruiting
2-21 years
All
Phase N/A

This study investigates treatments for Philadelphia chromosome positive acute lymphoblastic leukemia (ALL), a type of cancer affecting the blood and bone marrow. The purpose of this study is to examine the effectiveness of combining an investigational medication with different chemotherapy approaches to improve disease-free survival in children with standard risk ALL. The investigational medication is used alongside either a high-risk Children's Oncology Group (COG)/Berlin-Frankfurt-Munster (BFM) ALL chemotherapy backbone or a more intensive European (Es)PhALL chemotherapy backbone.

Participants will undergo specific procedures, including receiving the investigational medication and chemotherapy as part of their treatment plan. Chemotherapy involves using drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. The study will help determine which combination is more effective for patients.

  • Who can participate: Children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia can participate. They must have definitive evidence of BCR-ABL1 fusion by karyotype, FISH, or RT-PCR, not have started treatment with certain medications, and meet specific health criteria. Those with Down syndrome, a history of chronic myelogenous leukemia, or certain heart conditions are excluded.
  • Study details: Participants will receive an investigational medication alongside chemotherapy. Some will receive the medication with a standard chemotherapy regimen, while others will receive it with a more intensive regimen.
Study details
    Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)
    Chromosome-Positive Acute Lymphoblastic Leukemia
    Ph+ALL
    Lymphoblastic Leukemia
    Lymphoblastic
    Leukemia
    Cancer
    Oncology
    Pediatric
    Kid
    Kids
    Teen
    Teens
    Teenager
    Teenagers
    Child
    Children
    Adolescent
    Youth

TX8239

19 February 2024

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