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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Study ID
NCT03825367
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • AML, Childhood

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • 5-azacytidine — DRUG
    75mg/m2 subcutaneously will be given daily for 7 days on days 1 to 7.

Study Details

This is a phase I/II Study of Nivolumab in Combination with 5-azacytidine in pediatric patients with relapsed/refractory acute myeloid leukemia

Key Dates

Start date
Nov 29, 2019
Status verified
Oct 2022
Primary completion
May 31, 2023
Completion
Mar 30, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open label design
    Nivolumab and 5-azacytidine,

Primary Outcome Measure

Dose Toxicity [ Time Frame: 4 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Johns Hopkins UniversityBaltimoreMaryland21287-
Columbia University Medical CenterNew YorkNew York10032-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
St. Jude Children's Research HospitalMemphisTennessee38105-
Children's HealthDallasTexas75235-
Cook Children's Medical CenterFort WorthTexas76104-
Texas Children's Hospital/Baylor College of MedicineHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84108-
Seattle Children's HospitalSeattleWashington98101-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CAChildren's Healthcare of Atlanta· Atlanta, GAJohns Hopkins University· Baltimore, MDColumbia University Medical Center· New York, NYLevine Cancer Institute· Charlotte, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

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