Study on Venetoclax with Chemotherapy for Children with Acute Myeloid Leukemia

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05955261

Provider View

This clinical trial is testing if adding the drug venetoclax to standard chemotherapy is safe and effective for children with newly diagnosed acute myeloid leukemia (AML).

Patient Parameters

Program Overview

This study aims to find out if combining venetoclax with standard chemotherapy is safe and can help treat children with newly diagnosed acute myeloid leukemia (AML). The main goals are to see if this combination is tolerable and to measure how many patients have no minimal residual disease (MRD) after one course of treatment. The study will also look at the rates of complete remission, event-free survival, and overall survival in these patients.

Description

The treatment plan depends on the genetic features of the leukemia and how well the patient responds to therapy. Venetoclax will be given with each treatment cycle. Patients are categorized into low, intermediate, or high risk, which determines the number of chemotherapy courses they receive. Low-risk patients will have four courses, intermediate-risk patients will have five, and high-risk patients without a suitable stem cell donor will also have five courses. The criteria for a suitable stem cell donor and the preparation for stem cell transplant will follow local guidelines.

Intervention Details:

  • Low Risk:

    • Induction 1: Venetoclax taken by mouth daily from days -2 to 11, with other chemotherapy drugs given through IV on specific days.
    • Induction 2: Venetoclax taken by mouth daily from days 1 to 14, with other chemotherapy drugs given through IV on specific days.
    • Intensification: Venetoclax taken by mouth daily from days 1 to 7, with other chemotherapy drugs given through IV on specific days.

  • Intermediate Risk:

    • Induction 1: Similar to low risk.
    • Induction 2: Venetoclax taken by mouth daily from days 1 to 14, with other chemotherapy drugs given through IV on specific days.
    • Intensification: Venetoclax taken by mouth daily from days 1 to 7, with other chemotherapy drugs given through IV on specific days.

  • High Risk:

    • Induction 1: Similar to low risk.
    • Induction 2: Similar to intermediate risk.
    • Intensification: Treatment varies based on minimal residual disease (MRD) levels and availability of a stem cell donor.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) based on specific medical criteria.
  • Aged between 28 days and 22 years.
  • No previous treatment for AML, except for one dose of certain medications.
  • Female patients who can have children must have a negative pregnancy test before joining the study.
  • Participants who can have children must agree to use effective birth control during the study and for 6 months after.
  • Written consent from the patient and/or their parent or legal guardian.
  • Normal levels of direct bilirubin in the blood.

Exclusion Criteria

  • Patients with certain types of leukemia or genetic conditions are not eligible.
  • Patients with uncontrolled infections or other serious health issues that could affect safety or study results.
  • Previous exposure to certain chemotherapy drugs.
  • Cannot take certain medications that affect how the body processes drugs within 3 days of starting the study.

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