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

NCT02955589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-09-19

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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)

Conditions

  • Adult T-Cell Lymphoma (ATL)

Interventions

DRUG

HBI-8000

Oral, twice weekly

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY
  • HUYABIO International, LLC.

    lead INDUSTRY

Principal Investigators

  • Gloria Lee, MD · HUYA Bioscience International, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-12-31
Completion
2019-11-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955589 on ClinicalTrials.gov