Nivolumab in Combination With 5-azacytidine in Childhood Relapsed/Refractory AML

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

November 29, 2019

Primary Completion Date

May 31, 2023

Study Completion Date

March 30, 2024

Conditions
AML, Childhood
Interventions
DRUG

Nivolumab

"The dose of Nivolumab will be 3 mg/kg which is the adult recommended dose and is the recommended dose in children in the phase 2 portion of COG ADVL1412.~If 3 mg/kg is not tolerated in combination with 5-azacytidine, the dose will be stepped down to 1 mg/kg."

DRUG

5-azacytidine

75mg/m2 subcutaneously will be given daily for 7 days on days 1 to 7.

Trial Locations (12)

10032

Columbia University Medical Center, New York

21287

Johns Hopkins University, Baltimore

28204

Levine Cancer Institute, Charlotte

30322

Children's Healthcare of Atlanta, Atlanta

38105

St. Jude Children's Research Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

75235

Children's Health, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital/Baylor College of Medicine, Houston

84108

Primary Children's Hospital, Salt Lake City

90027

Children's Hospital of Los Angeles, Los Angeles

98101

Seattle Children's Hospital, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER