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

NCT03825367 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-10-12

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2023-05-31
Completion
2024-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825367 on ClinicalTrials.gov