CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
HBI-8000drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02955589
NCT02955589Phase 2Completed
CompareCT.gov

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)

HUYABIO International, LLC.·interventional·Posted Nov 4, 2016·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating HBI-8000 for Adult T-Cell Lymphoma (ATL). Completed, enrolled 23 participants across 15 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult T-Cell Lymphoma (ATL)
CountriesJapan
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2018
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.7 years ago

Interventions

HBI-8000drug

Oral, twice weekly