CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 7, 2017

Primary Completion Date

September 13, 2018

Study Completion Date

April 29, 2019

Conditions
Myelodysplastic SyndromesAcute Myeloid LeukemiaAMLMDS
Interventions
DRUG

CX-01

CX-01 at a dose of 4mg/kg on Day 1 of each 28-day cycle, followed by a continuous intravenous infusion at a dose of 0.25 mg/kg/hour for Days 1 through 7 of each cycle.

DRUG

Azacitidine

Azacitidine at a dose of 75mg/m\^2 on Days 1-7 of each 28-day cycle.

PROCEDURE

Bone marrow biopsy

-Baseline, day 28 of even-numbered cycle through Cycle 6, and end of study

PROCEDURE

Peripheral blood draw

-Day 1 of each cycle, day 3 of each cycle, day 7 of each cycle, day 28 of every even-numbered cycle through Cycle 6, and end of study

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cantex Pharmaceuticals

INDUSTRY

lead

Washington University School of Medicine

OTHER