NCT02955589

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

A Phase 2b Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: HUYABIO International, LLC. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)

Detailed description

This is a Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3 to 4 days between dosing. A treatment cycle is defined as 28 consecutive days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.

Conditions

• Adult T-Cell Lymphoma (ATL)

Interventions

Type	Name	Description
DRUG	HBI-8000	Oral, twice weekly

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-12-01
• Completion: 2019-11-01
• First posted: 2016-11-04
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

15 sites across 1 country: Japan