Peripheral T-Cell Lymphoma (PTCL)Phase 2NCT02953652
Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 2 study testing HBI-8000 in people with Peripheral T-Cell Lymphoma (PTCL), run by HUYABIO International, LLC. at 23 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma (PTCL)
- What is being tested?
- HBI-8000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Nov 2016to 17 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
- Platelets >75,000/µL independent of transfusion within 14 days of starting the study drug
- Hgb >8 g/dL independent of transfusion within 14 days of starting the study drug
- Serum creatinine < 1.5 X ULN
- Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamyl pyruvic transaminase (ALT/SGPT) less than or equal to 3 X ULN
- Serum Bilirubin less than or equal to 1.5 X ULN
- Negative serum pregnancy test for females of childbearing (reproductive) potential. Female patients of child bearing potential must use an effective method of birth control (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide or condom with spermicide) during treatment period and 1 month thereafter. Males must use an effective method of birth control (2 barrier methods) during treatment period and 3 months thereafter.
- Note: Female patients will be considered to be women of childbearing potential unless having undergone permanent contraception or postmenopausal. Postmenopausal is defined as at least 12 months without menses with no other medical reasons (e.g., chemical menopause because of treatment with anti-malignant tumor agents)
- Signed informed consent
Who cannot join
- 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
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- 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
- Hepatitis B surface antigen-positive, or hepatitis C virus antibody positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus DNA test (real-time PCR measurement) should be performed and if positive, the patient should be excluded from study
- Any history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Uncontrolled diabetes mellitus, hypertension, endocrine disorder, bleeding disorder
- Major surgery or radiation therapy within 28 days of starting the study drug
- Receiving investigational agents or anti-cancer therapy, within 28 days, nitrosourea or mitomycin C within 42 days of starting the study drug
- Receiving antibody therapy for PTCL within 12 weeks of starting the study drug
- Women who are breastfeeding or women who are not willing to stop breastfeeding during study treatment period and for 30 days after the last dose of study drug
- Potential for non-compliance or at increased risk based on investigator's judgement
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Japan18 sites
Study site
Akita
Study site
Bunkyōku
Study site
Chūōku
Study site
Fukuoka
Study site
Isehara
Study site
Kagoshima
Study site
Kobe
Study site
Kōtoku
Study site
Kumamoto
Study site
Kyoto
Study site
Maebashi
Study site
Nagoya
Study site
Okayama
Study site
Ōmura
Study site
Sapporo
Study site
Sayama
Study site
Suita
Study site
Yamagata
South Korea5 sites
Study site
Busan
Study site
Goyang-si
Study site
Incheon
Study site
Seongnam-si
Study site
Seoul
About this study
Official title: A Phase 2b Open-Label Single Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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).
Read the detailed description
This is a 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). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3-4 days between dosing. A cycle is defined as consecutive 28 days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.
- Conditions
- Peripheral T-Cell Lymphoma (PTCL)
- Being tested
- HBI-8000
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-8000Drug
Orally twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HBI-8000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 47 months.
Secondary outcomes (4)
Objective Response Rate by Disease Subtype
Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a CR or a PR according to IWC 2014 criteria and assessed by an IOERC.
CR: Target nodes/nodal masses must regress to <1.5 cm in LDi, no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no BM involvement.
PR: ≥50% decrease in 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.
Disease subtype (PTCL-NOS, AITL, ALCL, ALK, EATL) was assessed by Central Pathology Review (CPR).
Measured: Up to approximately 47 months.
Median Duration of Progression-free Survival (PFS)
PFS was defined as the duration from the date of the first study drug dose to the disease progression or death, whichever occurs first. PD was defined using the IWC 2014 criteria, as any new lesion or an individual node/lesion must be abnormal with: "LDi >1.5 cm" and "increase by 50% from perpendicular diameters nadir" and "an increase in LDi or shortest axis perpendicular to the LDi from nadir, 0.5 cm for lesions <2 cm or 1.0 cm for lesions >2 cm".
Measured: Up to approximately 47 months.
Median Duration of Response (DOR)
DOR was defined as the duration of response from first response (CR/PR) to disease progression or death, whichever occurs first. CR or PR according to the IWC 2014 criteria was assessed by an IOERC.
Measured: Up to approximately 47 months.
Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0
Safety evaluated as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
From date of first study drug to 30±3 days after the last dosing of the study drug or before the initiation of new cancer treatment.
Measured: Up to approximately 44 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-Cell Lymphoma (PTCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Gloria Lee, MD, Study chair, HUYABIO International, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953652
- Sponsor's protocol ID
- HBI-8000-203
- Status last verified
- Apr 2024
- First submitted
- 1 Nov 2016
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36200417
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Open-Label Single Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT02953652
- Acronym / sponsor ID
- HBI-8000-203
- Conditions
- Peripheral T-Cell Lymphoma (PTCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- Nov 2016
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a 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). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3-4 days between dosing. A cycle is defined as consecutive 28 days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBI-8000 | Experimental | Drug: HBI-8000Four 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histological or cytological diagnosis of the following peripheral T-cell lymphoma (PTCL) subtypes as defined by the WHO classification (2008) may be included:
- 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
Key exclusion criteria (23 listed)
- 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:
- Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-8000Orally twice weekly | Drug | HBI-8000 |
Primary outcome
Objective Response Rate
Time frame: Up to approximately 47 months.
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.
4 secondary outcomes
Objective Response Rate by Disease Subtype
Time frame: Up to approximately 47 months.
Median Duration of Progression-free Survival (PFS)
Time frame: Up to approximately 47 months.
Median Duration of Response (DOR)
Time frame: Up to approximately 47 months.
Safety Evaluated as Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0
Time frame: Up to approximately 44 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36200417Rai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Lee, MD study chair
HUYABIO International, LLC.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBI-8000 in people with Peripheral T-Cell Lymphoma (PTCL), run by HUYABIO International, LLC. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to approximately 47 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.