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

AML, Childhood Clinical Trial

Official title:
A Phase I/II Study of Nivolumab in Combination With 5-azacytidine in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (BMS Reference CA209-9JY)

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

This proposed study will be the first to test nivolumab in combination with AZA in pediatric patients with hematologic malignancies. Patients will receive the first dose of nivolumab on day 1 along with AZA. After "chemotherapy priming", a second dose of nivolumab will be given at day 15 which will enhance the effect of nivolumab on the regenerating CD4+ and CD8+ memory T cells. To establish a recommended Phase II dose (RP2D)of nivolumab in combination with 5-azacytidine in children with relapsed or refractory AML. To assess the clinical activity of Nivolumab in combination with 5-azacytidine in AML patients with M2/M3 disease at study entry. ;

Study Design

Related Conditions & MeSH terms

AML, Childhood

Clinical Trial Details

NCT number	NCT03825367
Study type	Interventional
Source	Therapeutic Advances in Childhood Leukemia Consortium
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	November 29, 2019
Completion date	March 30, 2024

View Details

See also
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