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

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT03825367
Trial Phases:	Phase I Phase II	Protocol IDs:	T2016-002 (primary) NCI-2019-06317
Eligibility:	1 - 30 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Therapeutic Advances in Childhood Leukemia Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT03825367

Summary

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

Objectives

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.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta
Arthur M. Blank Hospital
2220 North Druid Hills Road NE
Atlanta, GA 30329
404-785-0853
www.choa.org

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