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

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

July 25, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2034

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Venetoclax

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.

DRUG

Azacitidine

Given IV over 30 minutes on days 1-5

DRUG

Cytarabine

Given IV over 30 minutes q12 hours on days 1-8 (16 doses)

DRUG

Gemtuzumab Ozogamicin

Given IV

DRUG

Daunorubicin Hydrochloride

IV over 1 hour on days 1, 3, and 5

DRUG

Fludarabine Phosphate

Given IV over 30 minutes on days 1-5

DRUG

Idarubicin Hydrochloride

Given IV over 15 minutes on days 3-5

DRUG

Mitoxantrone Hydrochloride

IV over 1 hour on days 2-4

DRUG

Etoposide

Given IV over 1 hour on days 1-5

DRUG

Gilteritinib

PO on days 8-28 (21 doses)

Trial Locations (9)

20020

RECRUITING

Children's National Medical Center, Washington D.C.

28204

RECRUITING

Novant Health Presbyterian Medical Center, Charlotte

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

76104

RECRUITING

Cook Children's Medical Center, Fort Worth

92123

RECRUITING

Rady Children's Hospital-San Diego, San Diego

92868

RECRUITING

Children's Hospital of Orange County, Orange

93636

RECRUITING

Valley Children's Hospital, Madera

02115

RECRUITING

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER