NCT02737046

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

A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.

Conditions

• Adult T-cell Leukemia-Lymphoma
• ATLL

Interventions

Type	Name	Description
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.
DRUG	Lymphodepleting Therapy	OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy.

Timeline

• Start date: 2016-12-12
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2016-04-13
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study