Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 16, 2016

Primary Completion Date

April 2, 2019

Study Completion Date

April 2, 2019

Conditions
Relapsed Acute Myeloid Leukemia
Interventions
DRUG

Pembrolizumab

200 mg will be administered as a 30 minute IV infusion every 3 weeks. Every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).

DRUG

Decitabine

Will be administered at a dose of 20 mg/m\^2 by continuous intravenous infusion over 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7). Decitabine should be repeated every 6 weeks.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT02996474 - Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter