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
Status	Clinical Trial	Phase
Terminated	`NCT05077423` - A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia	Phase 1
Recruiting	`NCT06158828` - Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML	Phase 1/Phase 2
Recruiting	`NCT06221683` - Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML	Phase 2
Recruiting	`NCT06316960` - Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation	Phase 2
Withdrawn	`NCT05622591` - ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML	Phase 1
Recruiting	`NCT06326463` - CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies	Phase 1
Not yet recruiting	`NCT06389357` - Return to School Adaptation Programme for Children With Cancer	N/A
Terminated	`NCT04326439` - AflacLL1901 (CHOA-AML)	Phase 2