Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 19, 2021

Primary Completion Date

June 2, 2028

Study Completion Date

June 2, 2030

Conditions
PTCL
Interventions
DRUG

Azacytidine

Azacytidine, 300 mg po daily on Days 1-14

DRUG

Romidepsin

Romidepsin, 14 mg/m2 as an intravenous infusion over 4 hours on Days 8, 15, and 22 of a 35-day cycle

DRUG

Belinostat

Belinostat, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1-5 every 21 days.

DRUG

Pralatrexate

Pralatrexate, 30 mg/m2 as an intravenous infusion over a 3-5 minute push once weekly for 6 weeks of a 7 week treatment cycle.

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28 day cycle.

Trial Locations (5)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

22911

RECRUITING

University of Virginia, Charlottesville

27710

RECRUITING

Duke University, Durham

90822

RECRUITING

VA Long Beach Health Care System, Long Beach

06520

RECRUITING

Yale Cancer Center, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

University of Virginia

OTHER