Adding Dasatinib or Venetoclax to Improve Treatment in Children with Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT06390319

Provider View

This clinical trial is exploring whether adding dasatinib or venetoclax to standard treatment can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia, lymphoma, or mixed phenotype acute leukemia.

Patient Parameters

Program Overview

The study aims to find out if adding dasatinib or venetoclax to the usual treatment can help children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL), lymphoma (T-LLY), or mixed phenotype acute leukemia (MPAL) achieve better results. Researchers are particularly interested in seeing if these drugs can help more patients reach a state where no cancer cells are detectable after the initial treatment phase. They will also look at how long patients stay free of cancer and their overall survival rates.

Description

The treatment plan for this study includes three main phases: Induction, Early Post Induction, and Maintenance.

Induction Phase:

  • This phase lasts for about 4 weeks and includes several medications to help reduce cancer cells. Patients with T-ALL will receive dasatinib, while those with ETP or near-ETP ALL and MPAL will receive venetoclax. Patients with T-LLY will receive bortezomib. There will be a short break from chemotherapy at the end of this phase unless the cancer is not responding well.

Early Post Induction Phase:

  • This phase includes several steps:
    • Consolidation: Patients receive a combination of drugs over several weeks to further reduce cancer cells.
    • High-Dose Methotrexate: Given in cycles to help control the cancer.
    • Intensification: Additional treatment for patients with T-ALL or ETP/near-ETP.
    • Interim Therapy and Reinduction: Involves cycles of different medications to maintain progress and prevent cancer from returning.

Maintenance Therapy:

  • This phase helps keep the cancer from coming back and lasts for about 2¼ years. It includes regular doses of medications and periodic checks to ensure the cancer remains under control.

Patients will be monitored regularly throughout the study to track their progress and manage any side effects. The goal is to improve long-term outcomes for children and young adults with these types of leukemia and lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the INITIALL study.
  • Age between 1 and 18.99 years at the time of enrollment.
  • Diagnosed with T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia/lymphoma.
  • No prior chemotherapy except what is allowed by the INITIALL study.
  • Completed no more than 3 days of chemotherapy on INITIALL.
  • Meet specific blood and organ function criteria, including:
    • Direct bilirubin and ALT levels within specified limits for age.
    • Adequate kidney function as measured by creatinine levels or GFR.

Exclusion Criteria

  • Unable or unwilling to provide informed consent or assent.
  • Have severe nerve damage (Grade 2 or higher) if diagnosed with T-LLY.
  • Have a condition that prevents taking oral medications.
  • Known HIV infection or active hepatitis B or C.
  • Pregnant or breastfeeding.
  • Unwilling to use effective birth control during and after the study.
  • Taking certain medications or consuming specific foods that could interfere with the study drugs.

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105MemphisTennessee

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