drugset
drugset / Trial / NCT03417154

Nivolumab and Oral Cyclophosphamide for R/R AML and HIgh Risk MDS

NCT03417154 ↗

Phase 2 Completed 12 enrolled Masonic Cancer Center, University of Minnesota
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II trial of nivolumab and low dose cyclophosphamide (CTX) when given in combination to patients with relapsed/refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) who are not eligible for or decline hematopoietic stem cell transplant. It includes a randomized pilot sub-study during stage 1.

Timeline

Start
2018-08-13
Primary completion
2022-01-25
Completion
2022-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg Oral
Subject Cyclophosphamide Other / unclassified 350 mg Oral
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous

Indications

acute myeloid leukemia myelodysplastic syndrome