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

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

January 25, 2022

Study Completion Date

January 25, 2022

Conditions
Acute Myeloid LeukemiaHigher Risk Myelodysplastic Syndrome
Interventions
DRUG

Nivolumab

3mg/kg IV (or if prior alloHSCT, 1 mg/kg) over 30 minutes every 14 days on Days 1 and 15 for up to four 28-day courses.

DRUG

Low dose Cyclophosphamide (CTX) Daily

Oral cyclophosphamide 50mg + nivolumab 3 mg/kg IV every 2 weeks for up to 4 courses of treatment

DRUG

Low dose Cyclophosphamide (CTX) Every 7 Days

Oral cyclophosphamide 350 mg every 7 days + nivolumab 3mg/kg IV every 2 weeks for up to 4 courses of treatment

Trial Locations (1)

55455

University of Minnesota Masonic Cancer Center, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT03417154 - Nivolumab and Oral Cyclophosphamide for R/R AML and HIgh Risk MDS | Biotech Hunter | Biotech Hunter