70
Participants
Start Date
July 25, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
March 31, 2034
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.
Azacitidine
Given IV over 30 minutes on days 1-5
Cytarabine
Given IV over 30 minutes q12 hours on days 1-8 (16 doses)
Gemtuzumab Ozogamicin
Given IV
Daunorubicin Hydrochloride
IV over 1 hour on days 1, 3, and 5
Fludarabine Phosphate
Given IV over 30 minutes on days 1-5
Idarubicin Hydrochloride
Given IV over 15 minutes on days 3-5
Mitoxantrone Hydrochloride
IV over 1 hour on days 2-4
Etoposide
Given IV over 1 hour on days 1-5
Gilteritinib
PO on days 8-28 (21 doses)
RECRUITING
Children's National Medical Center, Washington D.C.
RECRUITING
Novant Health Presbyterian Medical Center, Charlotte
RECRUITING
St. Jude Children's Research Hospital, Memphis
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
Cook Children's Medical Center, Fort Worth
RECRUITING
Rady Children's Hospital-San Diego, San Diego
RECRUITING
Children's Hospital of Orange County, Orange
RECRUITING
Valley Children's Hospital, Madera
RECRUITING
Dana-Farber Cancer Institute, Boston
Collaborators (1)
AbbVie
INDUSTRY
St. Jude Children's Research Hospital
OTHER