Peripheral T-Cell Lymphoma, Not ClassifiedPhase 2NCT07081607
Golidocitinib With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.
A Phase 2 study testing golidocitinib with azacytidine and chidamide in people with Peripheral T-Cell Lymphoma, Not Classified, run by Ruijin Hospital.
Trial summary
In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma, Not Classified
- What is being tested?
- golidocitinib with azacytidine and chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 16 Jul 2028
- Phase
- Phase 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
- Histopathologically confirmed peripheral T-cell lymphoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
- Expected survival of ≥12 weeks;
- Measurable disease lesions;
- Any conditions considered ineligible for intenvive chemotherapy, including but not limted to age > 60 years, at least one comorbidity scored 3 points, or more than 4 comorbidities scored 2 points each according to the CIRS scale;
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to and adhere to effective contraceptive measures during the treatment period and for 180 days after the last dose of the study drug;
- Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up assessments.
Who cannot join
- Involvement of the central nervous system (CNS);
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Left ventricular ejection fraction<50%
- Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- Neutrophils<1.5×10^9/L
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- Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
- ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
- Creatinine is 1.5 times higher than the ULN.
- HIV-infected patients
- Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- Pregnant or lactation
- Require treatment with strong/moderate CYP3A inhibitors or inducers.
- Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
- Other medical conditions determined by the researchers that may affect 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: An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib Combined With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.
In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well.
This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.
- Being tested
- golidocitinib with azacytidine and chidamide
- Keywords
- Golidocitinib, Peripheral T-Cell Lymphoma
- 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.
golidocitinib with azacytidine and chidamideDrug
In Phase I, a "3+3" dose-escalation design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of golidocitinib: 150 mg every other day (QOD) and 150 mg once daily (QD).
In Phase II, we aim to evaluate the efficacy and safety of golidocitinib RP2D po in combination with chidamide 20mg biw po and azacytidine 100mg d1-7, SC in patients with peripheral T-cell lymphoma
| Study group | Role | What they receive |
|---|---|---|
| golidocitinib with azacytidine and chidamide | Experimental | Not described Receives: Drug: golidocitinib with azacytidine and chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year
Secondary outcomes (5)
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Complete Response Rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year.
Duration of Response
Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: From enrollment to study completion, a maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion16 Jul 2026 (estimated)
- Study completion16 Jul 2028 (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 Lymphoma, Not ClassifiedStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081607
- Sponsor's protocol ID
- PTCL-chemofree
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib Combined With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07081607
- Acronym / sponsor ID
- PTCL-chemofree
- Keywords
- Golidocitinib, Peripheral T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 16 Jul 2028 (estimated)
- First posted
- 23 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.
In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well.
This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| golidocitinib with azacytidine and chidamide | Experimental | Drug: golidocitinib with azacytidine and chidamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathologically confirmed peripheral T-cell lymphoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
- Expected survival of ≥12 weeks;
- Measurable disease lesions;
- Any conditions considered ineligible for intenvive chemotherapy, including but not limted to age > 60 years, at least one comorbidity scored 3 points, or more than 4 comorbidities scored 2 points each according to the CIRS scale;
Key exclusion criteria (15 listed)
- Involvement of the central nervous system (CNS);
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Left ventricular ejection fraction<50%
- Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
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 |
|---|---|---|
| golidocitinib with azacytidine and chidamideIn Phase I, a "3+3" dose-escalation design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of golidocitinib: 150 mg every other day (QOD) and 150 mg once daily (QD). In Phase II, we aim to evaluate the efficacy and safety of golidocitinib RP2D po in combination with chidamide 20mg biw po and azacytidine 100mg d1-7, SC in patients with peripheral T-cell lymphoma | Drug | golidocitinib with azacytidine and chidamide |
Primary outcome
Overall Response Rate
Time frame: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria
5 secondary outcomes
Progression-free survival
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Complete Response Rate
Time frame: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year.
Duration of Response
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to study completion, a maximum of 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 23 Jul 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 2 study testing golidocitinib with azacytidine and chidamide in people with Peripheral T-Cell Lymphoma, Not Classified, run by Ruijin Hospital.
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 15 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 23 Jul 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 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?
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 Wang Li (+86 02164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year). 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 23 Jul 2025.