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

Part of paid clinical trials in Madera, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05955261
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
29 Days - 21 Years
Healthy Volunteers
Not accepted

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)

Study Details

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

Key Dates

Start date
Jul 25, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2034

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Risk
    All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Etoposide, Mitoxantrone Hydrochloride, Gilteritinib
  • Experimental: Intermediate Risk
    All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Mitoxantrone Hydrochloride, Gilteritinib
  • Experimental: High Risk
    All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Azacitidine, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Gilteritinib

Primary Outcome Measure

Minimal residual disease (MRD)-negativity rate [ Time Frame: At day 29 after induction 1 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Valley Children's HospitalMaderaCalifornia93636-
Children's Hospital of Orange CountyOrangeCalifornia92868-
Rady Children's Hospital-San DiegoSan DiegoCalifornia92123-
Children's National Medical CenterWashington D.C.District of Columbia20020-
Ann & Robert H. Lurie Children's HospitalChicagoIllinois60611-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Novant Health Presbyterian Medical CenterCharlotteNorth Carolina28204-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
St. Jude Children's Research HospitalMemphisTennessee38105-
Cook Children's Medical CenterFort WorthTexas76104-

Find similar trials in Madera, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Valley Children's Hospital· Madera, CAChildren's Hospital of Orange County· Orange, CARady Children's Hospital-San Diego· San Diego, CAChildren's National Medical Center· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital· Chicago, ILDana-Farber Cancer Institute· Boston, MA

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