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RECRUITING Phase 2 ClinicalTrials.gov

A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

Sponsor: St. Jude Children's Research Hospital • ClinicalTrials.gov ID: NCT05955261

Registry updated: 2026-09-17
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Description

This is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: \- Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy

Interventions

  • Venetoclax (Drug)
    Venetoclax will be given with each course of therapy. Patients with low-risk AML will receive four courses of therapy, intermediate-risk patients will receive five courses of therapy, and high-risk patients will receive two or three courses of therapy followed by hematopoietic stem cell transplantation.
  • Azacitidine (Drug)
    Given IV over 30 minutes on days 1-5
  • Cytarabine (Drug)
    Given IV over 30 minutes q12 hours on days 1-8 (16 doses)
  • Gemtuzumab Ozogamicin (Drug)
    Given IV
  • Daunorubicin Hydrochloride (Drug)
    IV over 1 hour on days 1, 3, and 5
  • Fludarabine Phosphate (Drug)
    Given IV over 30 minutes on days 1-5
  • Idarubicin Hydrochloride (Drug)
    Given IV over 15 minutes on days 3-5
  • Mitoxantrone Hydrochloride (Drug)
    IV over 1 hour on days 2-4
  • Etoposide (Drug)
    Given IV over 1 hour on days 1-5
  • Gilteritinib (Drug)
    PO on days 8-28 (21 doses)

Eligibility criteria

Patients with preexisting conditions that may affect chemotherapy tolerance (e.g., bone marrow failure syndrome, cardiac disease, pulmonary disease, and history of significant hepatic impairment) should be discussed with study PI in detail to enable review of the medical history prior to enrollment onto AML23 study. Inclusion Criteria: * Diagnosis of AML fulfilling the criteria of the WHO classification of myeloid neoplasms or \< 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality or myeloid sarcoma or primary myelodysplastic syndrome (MDS) with ≥ 10% blasts or a complete blood count with the presence of at least 1,000 blasts/μL (e.g., a WBC count ≥ 10,000/μL with ≥ 10% blasts or a WBC count ≥ 5,000/μL with ≥ 20% blasts * Age \> 28 days and \< 22 years * No prior therapy for this malignancy except for one dose of intrathecal therapy and hydroxyurea or low-dose cytarabine (≤ 200 mg/m\^2 per day for ≤ 7 days) * Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment * Male and female participants of reproductive potential must agree to use an effective contraceptive method during the study and for 6 months after study treatment * Written informed consent from the patient and/or parent/legal guardian * Direct bilirubin ≤ 1.5 x institutional upper limit of normal Exclusion Criteria: * Patients with treatment-related AML, Down syndrome, acute promyelocytic leukemia, chronic myeloid leukemia in blast crisis, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible * Uncontrolled systemic fungal, bacterial, or viral infection or significant concurrent disease that would compromise patient safety or compliance, study participation, follow up, or interpretation of study results * Prior exposure to any dose of anthracycline or anthracenedione * Patients may not receive strong or moderate CYP3A inducers, such as rifampin, within 3 days of enrollment * Patients may not receive moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole) within 3 days of enrollment.

Conditions

Acute Myeloid Leukemia

Locations

  • Valley Children's Hospital — Madera, California, United States
  • Children's Hospital of Orange County — Orange, California, United States
  • Rady Children's Hospital-San Diego — San Diego, California, United States
  • Children's National Medical Center — Washington D.C., District of Columbia, United States
  • Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • St. Jude Children's Research Hospital — Memphis, Tennessee, United States
  • Cook Children's Medical Center — Fort Worth, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record