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

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 o

Trial Details

NCT ID

NCT05955261

Phase

PHASE2

Sponsor

St. Jude Children's Research Hospital

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Venetoclax
Azacitidine
Cytarabine
Gemtuzumab Ozogamicin
Daunorubicin Hydrochloride
Fludarabine Phosphate

Locations (sample)

Madera, California, United States|36.96134,-120.06072
Orange, California, United States|33.78779,-117.85311
San Diego, California, United States|32.71571,-117.16472
Washington D.C., District of Columbia, United States|38.89511,-77.03637
Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

Diagnosis of AML fulfilling the criteria of the WHO classification of myeloid neoplasms or \< 20% marrow myeloblasts and evidence of a clonal de no…
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 ≤…
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment

For full eligibility, visit ClinicalTrials.gov.

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