Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

May 7, 2020

Study Completion Date

May 7, 2020

Conditions
LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

Nivolumab

"Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I."

DRUG

Idarubicin

Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.

DRUG

Cytarabine

Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.

DRUG

Solu-medrol

Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.

DRUG

Dexamethasone

Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER