Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

NCT02953652 | Completed Phase 2 Results DMC

• 1 other identifier: HBI-8000-203
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Peripheral T-Cell Lymphoma (PTCL)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.

  Up to approximately 47 months.

Secondary Outcomes (4)

• Objective Response Rate by Disease Subtype

  Up to approximately 47 months.

• Median Duration of Progression-free Survival (PFS)

  Up to approximately 47 months.

• Median Duration of Response (DOR)

  Up to approximately 47 months.

• Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0

  Up to approximately 44 months.

Other Outcomes (5)

• Median Duration of Overall Survival (OS)

  Up to approximately 55 months.

• Pharmacokinetics (Cmax-selected Sites)

  0 (predose) up to 72 hours postdose on C1D1 and 0 (predose) up to 4 hours postdose on C2D1

• Pharmacokinetics AUC (0-INF)

  0 (predose) up to 72 hours postdose on C1D1

Study Arms (1)

HBI-8000

EXPERIMENTAL

Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity.

Drug: HBI-8000

Interventions

HBI-8000 DRUG

Orally twice weekly

HBI-8000

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of the following peripheral T-cell lymphoma (PTCL) subtypes as defined by the WHO classification (2008) may be included:
• PTCL, NOS
• Angioimmunoblastic T-cell lymphoma (AITL)
• Anaplastic large-cell lymphoma (ALCL), ALK+
• Anaplastic large-cell lymphoma (ALCL), ALK-
• Enteropathy-associated T-cell lymphoma (EATL)
• Hepatosplenic T-cell lymphoma
• Subcutaneous panniculitis-like T-cell lymphoma
• Patients for whom at least 1 measurable lesion is confirmed by the lesion assessment at baseline; an evaluable lesion is defined as more than 1.5 cm in greatest dimension and can be followed by imaging.
• Relapsed or refractory disease after receiving ≥1 prior systemic therapy with antitumor agent(s) and there is no other available treatment which can be considered appropriate for patients. Systemic therapy is defined as frontline chemotherapy or immunotherapy administered systemically.
• Male or female, age 20 years or older
• ECOG Performance Status of 0-2
• Life expectancy of greater than 3 months
• Meeting the following laboratory criteria for screening:
• Absolute Neutrophil Count \>1500/µL independent of growth factor support within 7 days of starting the study drug

You may not qualify if:

• Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm)
• Male patients with QTcF \> 450 msec at screening, female patients with QTcF \> 470 msec at screening or patients with congenital long QT syndrome, clinically significant arrhythmia, history of congestive heart failure (New York Heart Association Class III or IV) or acute myocardial infarction within 6 months of starting the study drug
• Patients with known hypersensitivity to benzamide class of compounds or any of the components of HBI-8000 tablets, and patients with prior exposure of HBI-8000
• Patients with a history of second malignancy other than disease under study. The exceptions are disease that has been treated with curative intent with no evidence of recurrence in past 2 years including:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Cervical carcinoma in situ
• Carcinoma in situ of the breast
• An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
• Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection
• Thyroid cancer with differentiated histology (e.g. papillary) treated with curative intent
• Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug
• History of allogeneic stem cell transplantation
• Organ transplantation recipients except autologous hematopoietic stem cell transplantation
• Uncontrolled inter-current infection

Sponsors & Collaborators

• HUYABIO International, LLC.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (23)

Unknown Facility

Akita, Japan

Location

Unknown Facility

Bunkyōku, Japan

Location

Unknown Facility

Chūōku, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kōtoku, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Maebashi, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Ōmura, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Sayama, Japan

Location

Unknown Facility

Suita, Japan

Location

Unknown Facility

Yamagata, Japan

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Goyang-si, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seongnam-si, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• Rai S, Kim WS, Ando K, Choi I, Izutsu K, Tsukamoto N, Yokoyama M, Tsukasaki K, Kuroda J, Ando J, Hidaka M, Koh Y, Shibayama H, Uchida T, Yang DH, Ishitsuka K, Ishizawa K, Kim JS, Lee HG, Minami H, Eom HS, Kurosawa M, Lee JH, Lee JS, Lee WS, Nagai H, Shindo T, Yoon DH, Yoshida S, Gillings M, Onogi H, Tobinai K. Oral HDAC inhibitor tucidinostat in patients with relapsed or refractory peripheral T-cell lymphoma: phase IIb results. Haematologica. 2023 Mar 1;108(3):811-821. doi: 10.3324/haematol.2022.280996.

  PMID: 36200417 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

HBI-8000

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Huya Japan Clinical Development
• Organization: Huya Japan G.K.

japanclinical@huyabio.com

Study Officials

• Gloria Lee, MD

  HUYABIO International, LLC.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5); JP (18)