Peripheral T Cell LymphomaPhase 1/2NCT07093710
Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 1/2 study testing Golidocitinib, Mitoxantrone Hydrochloride Liposome and Chidamide in people with Peripheral T Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Golidocitinib, Mitoxantrone Hydrochloride Liposome and Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2025to 1 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
- Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center
- Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion
- Age ≥ 18 years
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate organ and bone marrow function
Who cannot join
- Accompanied by hemophagocytic lymphohistiocytosis (HLH)
- Lymphoma involvement in the central nervous system or meninges
- Active infections
- Uncontrolled clinical cardiac symptoms or diseases
- Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
- Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).
- History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Patients with mental disorders or those unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong
About this study
Official title: The Safety and Efficacy of Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib/II Clinical Study
This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Golidocitinib, Mitoxantrone Hydrochloride Liposome, Chidamide
- 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.
GolidocitinibDrug
150mg, po, qd;
Mitoxantrone Hydrochloride LiposomeDrug
Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)
ChidamideDrug
Cohort 2: Chidamide：20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx | Experimental | In Cohort 1, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Mitoxantrone Hydrochloride Liposome, with an initial dose of 15mg/m² of Liposomal Mitoxantrone. Two dose groups are designed: 15mg/m² and 18mg/m². Each treatment cycle is 28 days. The Mitoxantrone Hydrochloride Liposome injection will be combined with Golidocitinib(150mg, qd) at the RP2D dose level for an extension study.
In Cohort 2, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Chidamide, with an initial dose of 20 mg (biw) of Chidamide. Two dose groups are designed: 20 mg and 30 mg. Each treatment cycle is 28 days. The Chidamide will be combined with Golidocitinib (150mg, qd) at the RP2D dose level for an extension study. Receives: Drug: Golidocitinib; Drug: Mitoxantrone Hydrochloride Liposome; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Measured: Up to 24 months
Maximum tolerated dose (MTD) for Phase 1b
To identify the MTD
Measured: The first cycle after administration
Secondary outcomes (4)
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Measured: Up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start27 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (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 Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093710
- Sponsor's protocol ID
- B2025-346
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib/II Clinical Study
- ClinicalTrials.gov ID
- NCT07093710
- Acronym / sponsor ID
- B2025-346
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 30 Jul 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 prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx | Experimental | Drug: Golidocitinib, Drug: Mitoxantrone Hydrochloride Liposome, Drug: ChidamideIn Cohort 1, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Mitoxantrone Hydrochloride Liposome, with an initial dose of 15mg/m² of Liposomal Mitoxantrone. Two dose groups are designed: 15mg/m² and 18mg/m². Each treatment cycle is 28 days. The Mitoxantrone Hydrochloride Liposome injection will be combined with Golidocitinib(150mg, qd) at the RP2D dose level for an extension study. In Cohort 2, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Chidamide, with an initial dose of 20 mg (biw) of Chidamide. Two dose groups are designed: 20 mg and 30 mg. Each treatment cycle is 28 days. The Chidamide will be combined with Golidocitinib (150mg, qd) at the RP2D dose level for an extension study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
- Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center
- Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion
- Age ≥ 18 years
- Expected survival greater than 12 weeks
Key exclusion criteria (8 listed)
- Accompanied by hemophagocytic lymphohistiocytosis (HLH)
- Lymphoma involvement in the central nervous system or meninges
- Active infections
- Uncontrolled clinical cardiac symptoms or diseases
- Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
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 |
|---|---|---|
| Golidocitinib150mg, po, qd; | Drug | Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx |
| Mitoxantrone Hydrochloride LiposomeCohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study) | Drug | Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx |
| ChidamideCohort 2: Chidamide：20mg/30mg, po, Biw (phase Ib); RP2D (phase II study) | Drug | Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx |
Primary outcome
Overall response rate(ORR) for Phase 2
Time frame: Up to 24 months
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Maximum tolerated dose (MTD) for Phase 1b
Time frame: The first cycle after administration
To identify the MTD
4 secondary outcomes
Complete response rate (CRR)
Time frame: Up to 24 months
Duration of Response(DOR)
Time frame: Up to 4 years
Progression-free survival(PFS)
Time frame: Up to 4 years
Overall survival(OS)
Time frame: Up to 4 years
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 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Golidocitinib, Mitoxantrone Hydrochloride Liposome and Chidamide in people with Peripheral T Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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 Qingqing Cai (+862087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate(ORR) for Phase 2 (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 31 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.