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Peripheral T Cell LymphomaPhase 1/2NCT07209163

Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma

A Phase 1/2 study testing Tazemetostat, Linperlisib and Golidocitinib in people with Peripheral T Cell Lymphoma, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Tazemetostat, Linperlisib and Golidocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Oct 2025to Mar 2027
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

  • fully understood and voluntarily signed the ICF for this study
  • aged ≥ 18 years;
  • patients with R/R PTCL who have received at least one prior systemic therapy.
  • Patients must have at least one measurable lesion by computed tomography (CT)/magnetic resonance imaging (MRI) (longest diameter of lymph node lesions > 1.5 cm or longest diameter of extranodal lesions > 1 cm); evaluable lesions: PET-CT examination showed increased local uptake in lymph nodes or extranodal sites (higher than liver) and imaging characteristics consistent with lymphoma performance
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
  • Adequate bone marrow function, renal function, liver function: ANC ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, platelets ≥ 75 × 109/L Note: if the investigator believes that the patient 's above test values are below the lower limit of the protocol due to lymphoma invading the bone marrow, the patient can be enrolled after assessment.Creatinine clearance > 40 mL/min, calculated by Cockcroft-Gault method: • serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for unconjugated bilirubinemia in Gilbert 's syndrome; • ALP (in the absence of bone disease), ALT, and AST ≤ 3.0 × ULN (in the presence of liver metastases, ≤ 5 × ULN); • international normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
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  • Current negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV), and inactive if positive:
  • HBV infected patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb)] but negative results of HBV DNA polymerase chain reaction (PCR) test can be enrolled; these patients require continuous antiviral therapy after enrollment and HBV DNA PCR test is performed every cycle;
  • Patients with positive HCV serology but negative HCV RNA test may be enrolled;
  • CMV IgM antibody positive,However, patients who tested negative for CMV DNA could be enrolled;
  • female patients of childbearing potential had to agree to use a double contraception method at least 28 days before starting study drug, during treatment, and for 6 months after the last dose of study drug, and male patients with partners of childbearing potential had to also use an effective double contraception method during the study and for 3 months after the last dose of study drug, e.g., condom, sponge plug, foam, contraceptive jelly, diaphragm cap or intrauterine contraceptive device, contraceptive pills (oral or parenteral), contraceptive implant (Implanon ®), injectable intravascular injection, or other contraceptive measures.Postmenopausal women (> 45 years of age and amenorrheic for > 1 year) and surgically sterile women are exempt from this criterion.

Who cannot join

  • Patients who meet any of the following exclusion criteria must be excluded from this study:
  • previously used drugs in the treatment regimen may affect the efficacy evaluation of this study (assessed by the investigator)
  • previous bone marrow malignancies, including MDS, AML, MPN, etc.
  • and have clinically significant abnormal test results as judged by the investigator;
  • inability to be orally administered, previous surgical history or severe gastrointestinal diseases such as dysphagia, active gastric ulcer, etc., which the investigator believes may affect the absorption of the study drug;
  • major surgery within 4 weeks before the first study drug administration (referring to grade 3 and 4 surgery as specified in the Measures for the Administration of Clinical Application of Medical Technology implemented on May 1, 2009);
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  • current clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or a history of myocardial infarction within 6 months after screening.Left ventricular ejection fraction < 50% measured by echocardiography
  • Venous thrombosis or pulmonary embolism within 3 months before study drug administration;
  • History of stroke or intracranial hemorrhage within 6 months before the first study drug administration;
  • Active infection requiring systemic treatment;
  • History of inflammatory bowel disease (eg, Crohn 's disease or ulcerative colitis);
  • Known hypersensitivity to study drug;
  • Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality of significant clinical significance that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that would make the use of the study drug inappropriate or would compromise the interpretation of the study results or put the patient at high risk.
  • pregnant (positive pregnancy test) or lactating women;
  • patients who have had previous organ transplantation;
  • diagnosed or treated for malignancies other than PTCL, with the following exceptions: a) malignancies treated with curative therapy ≥ 3 years before randomization and without known active disease; b) adequately treated non-melanoma skin cancer or malignancies without evidence of disease

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mingci Cai, MD contact

02164370045 ext. 665257

cmc_girl@163.com

Shu Cheng, MD contact

02164370045 ext. 665257

About this study

Official title: An Open-label, Single-arm Study Evaluating the Safety and Efficacy of Tazemetostat in Combination With Linperlisib/Golidocitinib in Patients With Relapsed/Refractory 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. EZH2 inhibitor like Tazemetostat or SHR 2554 has been demonstrated its anti-tumor activity in PTCL either alone or in combination with other targeted agents.

This study aims to explore the efficacy and safety of Tazemetostat in combination with Linperlisib/Golidocitinib in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma in the patients with peripheral T-cell lymphoma according to next-generation sequesing results.

Being tested
Tazemetostat, Linperlisib, Golidocitinib
Keywords
Peripheral T-Cell Lymphoma, Tazemetostat, Linperlisib, Golidocitinib
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.

  • TazemetostatDrug

    Tazemetostat 800mg, twice once daily (BID), orally

  • LinperlisibDrug

    In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Linperlisib: 60 mg once daily (QD) and 60 mg QD, orally.

    In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Linperlisib RP2D in patients with peripheral T-cell lymphoma with co-RHOA/TET2mut.

  • GolidocitinibDrug

    In Phase I, BOIN design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of Lgolidocitinib: 150 mg every other day (QOD) and 150 mg QD, orally.

    In Phase II, BOP2 design will be adopted to enroll around 24 participants, aiming to evaluate the efficacy and safety of Tazemetostat with Golidocitinib RP2D in patients with peripheral T-cell lymphoma without co-RHOA/TET2mut.

Study groups in NCT07209163
Study groupRoleWhat they receive
Tazemetostat With LinperlisibExperimentalNot described
Receives: Drug: Tazemetostat; Drug: Linperlisib
Tazemetostat With GolidocitinibExperimentalNot described
Receives: Drug: Tazemetostat; Drug: Golidocitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 28 days) through study completion, an average of 1 year.

Secondary outcomes (5)

  1. 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 2 years).

  2. 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.

  3. 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 2 years).

  4. 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).

  5. 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 2 years]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07209163
Sponsor's protocol ID
PTCL-EZH2
Status last verified
Sep 2025
First submitted
30 Sep 2025
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tazemetostat, Linperlisib and Golidocitinib in people with Peripheral T Cell Lymphoma, 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 11 inclusion and 16 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 6 Oct 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 Mingci Cai, MD (02164370045 ext. 665257, cmc_girl@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 28 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?

On the ClinicalTrials.gov record for NCT07209163.

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 6 Oct 2025.

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