APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)

PHASE3CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

January 11, 2019

Primary Completion Date

November 27, 2020

Study Completion Date

January 14, 2022

Conditions
MDS
Interventions
DRUG

APR-246 + azacitidine

"Patients will be randomized (1:1) to one of two arms: stratified by age (\< 65 years versus ≥ 65):~Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine"

DRUG

Azacitidine

"Patients will be randomized (1:1) to one of two arms: stratified by age (\< 65 years versus ≥ 65):~Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine"

Trial Locations (27)

10065

Cornell Medical Center, New York

Memorial Sloan Kettering Cancer Center, New York

12902

Moffitt Cancer Center, Tampa

15232

University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh

19023

Fred Hutchinson Cancer Research Center, Seattle

19104

University of Pennsylvania, Abramson Cancer Center, Philadelphia

21287

Johns Hopkins Medical Center, Baltimore

31100

IUCT Oncopole, Toulouse

32224

Mayo Clinic Jacksonville, Jacksonville

33021

Memorial Health Care System South Florida, Hollywood

37232

Vanderbilt University Medical Center, Nashville

44093

CHU Nantes, Nantes

44195

Cleveland Clinic, Cleveland

52242

University of Iowa Hospitals and Clinics, Holden Cancer Center, Iowa City

55902

Mayo Clinic Rochester, Rochester

60611

Robert H Lurie Comprehensive Cancer Center, Northwestern University, Chicago

60637

University Of Chicago Medicine, Chicago

63130

Washington University St. Louis, St Louis

70121

Ochsner Cancer Institute, New Orleans

75010

Hôpital Saint-Louis, Paris

77030

MD Anderson Cancer Center, Houston

91010

City of Hope, Duarte

94304

Stanford University Cancer Research Center, Palo Alto

06510

Yale Cancer Center, New Haven

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

06000

CHU Nice, Nice

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aprea Therapeutics

INDUSTRY

NCT03745716 - APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS) | Biotech Hunter | Biotech Hunter