54
Participants
Start Date
November 11, 2022
Primary Completion Date
November 11, 2025
Study Completion Date
November 11, 2027
Tagraxofusp
Dose will be assigned at study entry. Give IV over 15 minutes.
Fludarabine
"30 mg/m\^2 will be given IV over 30 minutes on days 1-5.~Infusion will start 30 minutes after start of tagraxofusp on days 4 and 5."
Cytarabine
2000 mg/m2 intravenously will be given daily over 1-3 hours for 5 days on days 1 through 5. Infusion will begin 4 hours after start of fludarabine. Because of an increased risk of neurotoxicity, it is recommended that IT cytarabine be separated from high dose IV cytarabine administration by at least 24 hours on C1D1.
Dexamethasone
"* 20 mg/m2/day divided BID (max 40 mg/day) given orally on days 1 through 5 and 15 through 19. The two doses should be separated by at least 8 hours.~* Any oral formulation of dexamethasone is acceptable.~* IV may be given if oral formulation is not tolerated"
Vincristine
"* 1.5 mg/m2 (maximum dose 2 mg) given intravenously as an IV push over 1-5 minutes or infusion via minibag as per institutional policy on days 1, 8, 15, and 22.~* Infusion will start 30 minutes after start of tagraxofusp on day 8."
Azacitidine
"* 75 mg/m2 subcutaneously or intravenously will be given daily over 15 minutes for 5 days on days 1 through 5.~* Azacitidine will be given 30-60 minutes before beginning the tagraxofusp infusion."
Methotrexate
"Give intrathecally:~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients ≥9 years of age"
Cytarabine IT
"Give intrathecally:~* 30 mg for patients age 1-1.99~* 50 mg for patients age 2-2.99~* 70 mg for patients ≥3 years of age~If given as part of Triple IT Therapy:~AML Patients:~Age 1-1.99 - 24 mg Age 2-2.99 - 30 mg Age ≥3 years of age - 36 mg~AML Patients:~Age 1-1.99 - 16 mg Age 2-2.99 - 20 mg Age 3-8.99 - 24 mg Age ≥9 years of age - 30 mg"
Hydrocortisone
"Given intrathecally.~AML Patients:~Age 1-1.99 - 16 mg Age 2-2.99 - 20 mg Age ≥3 years of age - 24 mg~AML Patients:~Age 1-1.99 - 8 mg Age 2-2.99 - 10 mg Age 3-8.99 - 12 mg Age ≥9 years of age - 15 mg"
NOT_YET_RECRUITING
Children's Hospital New York-Presbyterian, New York
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
NOT_YET_RECRUITING
Children's Hospital of Philadelphia, Philadelphia
RECRUITING
Children's National Medical Center, Washington D.C.
NOT_YET_RECRUITING
National Cancer Institute, Pediatric Oncology Branch, Bethesda
NOT_YET_RECRUITING
Johns Hopkins University, Baltimore
NOT_YET_RECRUITING
Carolina-Levine Children's Hospital, Charlotte
NOT_YET_RECRUITING
Children's Healthcare of Atlanta, Emory University, Atlanta
NOT_YET_RECRUITING
University of Miami, Miami
NOT_YET_RECRUITING
St. Jude Children's Research Hospital, Memphis
NOT_YET_RECRUITING
Nationwide Children's Hospital, Columbus
NOT_YET_RECRUITING
Rainbow Babies, Cleveland
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
Riley Hospital for Children, Indianapolis
RECRUITING
Children's Hospital of Wisconsin, Milwaukee
NOT_YET_RECRUITING
Children's Hospital and Clinics of Minnesota, Minneapolis
RECRUITING
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
RECRUITING
University of Texas, Southwestern, Dallas
RECRUITING
Cook Children's Hospital, Fort Worth
RECRUITING
Texas Children's Hospital/Baylor College of Medicine, Houston
RECRUITING
Children's Hospital Colorado, Denver
RECRUITING
Primary Children's Hospital, Salt Lake City
RECRUITING
Children's Hospital Los Angeles, Los Angeles
NOT_YET_RECRUITING
Children's Hospital Orange County, Orange
NOT_YET_RECRUITING
Oregon Health & Science University, Portland
NOT_YET_RECRUITING
Seattle Children's Hospital, Seattle
RECRUITING
UCSF School of Medicine, San Francisco
NOT_YET_RECRUITING
Dana-Farber Cancer Institute, Boston
RECRUITING
C.S. Mott Children's Hospital, Ann Arbor
RECRUITING
Children's Hospital at Westmead, Westmead
NOT_YET_RECRUITING
Sydney Children's Hospital, Sydney
Therapeutic Advances in Childhood Leukemia Consortium
OTHER