Peripheral T-cell LymphomaPhase 1/2NCT06757387
Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma
A Phase 1/2 study testing chidamide and golidocitinib in people with Peripheral T-cell Lymphoma, run by Peking University Cancer Hospital & Institute.
Trial summary
This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- chidamide and golidocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must fully understand the study, voluntarily participate, and sign an informed consent form.
- The subject must be ≥ 18 years of age and ≤ 80 years of age, of either sex.
- The subject must have a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), NK/T-cell lymphoma, anaplastic large cell lymphoma ALK-positive (ALCL ALK+), anaplastic large cell lymphoma ALK-negative (ALCL ALK-), enteropathy-associated T-cell lymphoma, and hepatosplenic T-cell lymphoma.
- The subject must have relapsed or refractory disease following prior systemic therapy (including autologous hematopoietic stem cell transplantation). Note: The subject must have received ≥1 and ≤3 prior lines of systemic therapy. Relapsed is defined as recurrence following a CR. Refractory is defined as disease with stable disease (SD) or progressive disease (PD) during interim efficacy assessment with prior systemic chemotherapy, or failure to achieve a CR at the end of treatment and need for further therapy.
- The subject must have at least one evaluable or measurable lesion according to the Lugano 2014 criteria:Lymph node lesions: Measurable lymph nodes must have a long axis >1.5 cm.
- Non-lymph node lesions: Measurable extranodal lesions must have a long axis >1.0 cm.
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- The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- The subject must meet the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L. Platelet count (PLT) ≥ 100 × 10^9/L (≥ 50 × 10^9/L if with bone marrow infiltration).
- Hemoglobin (HB) ≥ 80 g/L. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the ULN.
- Serum creatinine (Scr) ≤ 1.5 times the ULN.
- The subject must not have received any radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 3 weeks prior to enrollment.
- The investigator must determine that the subject has a life expectancy of at least 6 months.
Who cannot join
- Subjects with central nervous system (CNS) involvement and/or concomitant hemophagocytic lymphohistiocytosis (HLH).
- Prior treatment with a JAK inhibitor (e.g., golidocitinib).
- Prior treatment with an HDAC inhibitor within 3 weeks before the start of study treatment.
- Impaired cardiac function or significant cardiac disease, including, but not limited to:
- Myocardial infarction, congestive heart failure, or viral myocarditis within 6 months prior to screening; symptomatic cardiac disease requiring medical intervention, such as unstable angina or arrhythmia.
- Cardiac functional class ≥ III (New York Heart Association (NYHA) functional classification).
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- Ejection fraction (EF) less than 50% or below the lower limit of normal of the study site's standard by echocardiogram.
- A history of persistent cardiomyopathy. QT corrected by Fridericia's formula (QTcF) > 450 milliseconds, or a congenital long QT syndrome.
- Hepatitis B (positive hepatitis B surface antigen or positive hepatitis B core antibody) or Hepatitis C (positive HCV antibody or HCV-RNA titer above the upper limit of normal at the study site).
- Uncontrolled active infection (viral, bacterial, fungal, etc., such as infectious pneumonia) or a requirement for non-oral anti-infective treatment.
- Major surgery within 4-6 weeks prior to screening or scheduled major surgery during the study.
- Uncontrolled hypertension at screening, uncontrolled diabetes at screening.
- A history of active visceral bleeding within 3 months prior to screening.
- History of malignancy within the past 5 years that may interfere with protocol implementation or results analysis (with the exception of treated basal cell skin cancer, cervical carcinoma in situ, breast carcinoma in situ, in situ gastrointestinal mucosal cancer, and localized prostate cancer).
- a) Post solid organ transplant. b). A history of allogeneic hematopoietic stem cell transplantation.
- History of psychiatric illness or cognitive impairment.
- A history of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) and a history of drug dependence (sedatives, hypnotics, analgesics, narcotics, stimulants, and psychomimetic drugs, etc.).
- Women who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) or male patients whose partners are unwilling or unable to use effective methods of contraception for the duration of the study and for 12 weeks after the last dose of the study drug. [WOCBP includes: any woman who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.
- Any condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II, Open-Label, Single-Arm Study of Chidamide in Combination With Golidocitinib in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.
Read the detailed description
Phase I Study:
The Phase I study will enroll an estimated 6 to 12 subjects. Using a 3+3 dose-escalation design, three dose levels of chidamide and golidocitinib will be explored. Enrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW), according to enrollment time. Starting with the lowest dose level, three patients will be treated at each dose level and observed for toxicity during the first cycle. If no dose-limiting toxicity (DLT) is observed, the next higher dose level will be investigated. If one DLT is observed, an additional three patients will be treated at that dose level. Dose escalation will continue if no further DLTs are observed in these additional patients, but will terminate if a DLT occurs. If more than one DLT occurs among the initial three patients, dose escalation will terminate. The dose level immediately below that at which the DLT is determined will be established as the maximum tolerated dose (MTD).
If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus. Each subject will receive only one dose level and schedule during the study. After completion of the treatment period, subjects will enter the follow-up period.
Phase II Study:
The Phase II study is expected to enroll approximately 28 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Patients will receive treatment with golidocitinib and chidamide. The doses of chidamide and golidocitinib will be the RP2D established in the Phase I study. Each treatment cycle will be 21 days in duration. Subjects will continue to receive treatment per the investigator's assessment, until documented disease progression, intolerable toxicity, withdrawal of consent, or if the subject meets other criteria for treatment discontinuation (whichever occurs first).
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- chidamide and golidocitinib
- Keywords
- PTCL
- 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.
chidamide and golidocitinibDrug
Enrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW)； If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment Group | Experimental | Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD) Receives: Drug: chidamide and golidocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicities (DLTs)
A Dose-Limiting Toxicity (DLT) is defined as any of the following events that occur within the first cycle of combination therapy and are considered possibly related (including definitely related, probably related) to the investigational drug(s):
Grade 4 neutropenia lasting for more than 5 days. Grade ≥3 neutropenia with fever (neutrophil count <1.0 × 10^9/L with a single temperature >38.3°C or a temperature ≥38°C lasting for more than 1 hour).
Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with a bleeding tendency. Grade 4 anemia. Grade 3 nausea or vomiting persisting for more than 48 hours despite antiemetic treatment.
Grade 4 nausea or vomiting. Grade ≥3 QTc prolongation or Grade ≥2 other cardiac toxicity. Grade ≥3 non-hematologic toxicity (excluding nausea and vomiting that is not responsive to treatment).
Treatment delay of more than 2 weeks in cycle 2 due to tolerability issues. Other: Clinically significant, intolerable toxicities, determined by investigator discussion t
Measured: within 28 days
Secondary outcomes (1)
objective response rate (ORR)
Objective response rate (ORR) based on CT images,ORR is calculated by adding the number of patients who achieve a Complete Response (CR) to the number of patients who achieve a Partial Response (PR).
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqin Song, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757387
- Sponsor's protocol ID
- CSIIT-T42
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Single-Arm Study of Chidamide in Combination With Golidocitinib in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06757387
- Acronym / sponsor ID
- CSIIT-T42
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- PTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.
Detailed description
Phase I Study:
The Phase I study will enroll an estimated 6 to 12 subjects. Using a 3+3 dose-escalation design, three dose levels of chidamide and golidocitinib will be explored. Enrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW), according to enrollment time. Starting with the lowest dose level, three patients will be treated at each dose level and observed for toxicity during the first cycle. If no dose-limiting toxicity (DLT) is observed, the next higher dose level will be investigated. If one DLT is observed, an additional three patients will be treated at that dose level. Dose escalation will continue if no further DLTs are observed in these additional patients, but will terminate if a DLT occurs. If more than one DLT occurs among the initial three patients, dose escalation will terminate. The dose level immediately below that at which the DLT is determined will be established as the maximum tolerated dose (MTD).
If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus. Each subject will receive only one dose level and schedule during the study. After completion of the treatment period, subjects will enter the follow-up period.
Phase II Study:
The Phase II study is expected to enroll approximately 28 patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Patients will receive treatment with golidocitinib and chidamide. The doses of chidamide and golidocitinib will be the RP2D established in the Phase I study. Each treatment cycle will be 21 days in duration. Subjects will continue to receive treatment per the investigator's assessment, until documented disease progression, intolerable toxicity, withdrawal of consent, or if the subject meets other criteria for treatment discontinuation (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Treatment Group | Experimental | Drug: chidamide and golidocitinibDose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject must fully understand the study, voluntarily participate, and sign an informed consent form.
- The subject must be ≥ 18 years of age and ≤ 80 years of age, of either sex.
- The subject must have a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), NK/T-cell lymphoma, anaplastic large cell lymphoma ALK-positive (ALCL ALK+), anaplastic large cell lymphoma ALK-negative (ALCL ALK-), enteropathy-associated T-cell lymphoma, and hepatosplenic T-cell lymphoma.
- The subject must have relapsed or refractory disease following prior systemic therapy (including autologous hematopoietic stem cell transplantation). Note: The subject must have received ≥1 and ≤3 prior lines of systemic therapy. Relapsed is defined as recurrence following a CR. Refractory is defined as disease with stable disease (SD) or progressive disease (PD) during interim efficacy assessment with prior systemic chemotherapy, or failure to achieve a CR at the end of treatment and need for further therapy.
- The subject must have at least one evaluable or measurable lesion according to the Lugano 2014 criteria:Lymph node lesions: Measurable lymph nodes must have a long axis >1.5 cm.
Key exclusion criteria (19 listed)
- Subjects with central nervous system (CNS) involvement and/or concomitant hemophagocytic lymphohistiocytosis (HLH).
- Prior treatment with a JAK inhibitor (e.g., golidocitinib).
- Prior treatment with an HDAC inhibitor within 3 weeks before the start of study treatment.
- Impaired cardiac function or significant cardiac disease, including, but not limited to:
- Myocardial infarction, congestive heart failure, or viral myocarditis within 6 months prior to screening; symptomatic cardiac disease requiring medical intervention, such as unstable angina or arrhythmia.
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 |
|---|---|---|
| chidamide and golidocitinibEnrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW)； If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus. | Drug | Combination Treatment Group |
Primary outcome
dose-limiting toxicities (DLTs)
Time frame: within 28 days
A Dose-Limiting Toxicity (DLT) is defined as any of the following events that occur within the first cycle of combination therapy and are considered possibly related (including definitely related, probably related) to the investigational drug(s): Grade 4 neutropenia lasting for more than 5 days. Grade ≥3 neutropenia with fever (neutrophil count <1.0 × 10^9/L with a single temperature >38.3°C or a temperature ≥38°C lasting for more than 1 hour). Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with a bleeding tendency. Grade 4 anemia. Grade 3 nausea or vomiting persisting for more than 48 hours despite antiemetic treatment. Grade 4 nausea or vomiting. Grade ≥3 QTc prolongation or Grade ≥2 other cardiac toxicity. Grade ≥3 non-hematologic toxicity (excluding nausea and vomiting that is not responsive to treatment). Treatment delay of more than 2 weeks in cycle 2 due to tolerability issues. Other: Clinically significant, intolerable toxicities, determined by investigator discussion t
1 secondary outcome
objective response rate (ORR)
Time frame: within 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing chidamide and golidocitinib in people with Peripheral T-cell Lymphoma, run by Peking University Cancer Hospital & Institute.
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 13 inclusion and 19 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: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuqin NA Song, Medical Doctor (MD) (+86-13910333346, zj@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicities (DLTs) (time frame: within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2025.