Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 12, 2016

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Adult T-cell Leukemia-LymphomaATLL
Interventions
DRUG

Belinostat

Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.

DRUG

Zidovudine

Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.

DRUG

Interferon-Alfa-2b

OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.

DRUG

Pegylated Interferon-Alfa-2b

OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER