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.
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
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;
Parallel
Tazemetostat
DrugTazemetostat 800mg, twice once daily (BID), orally
Linperlisib
DrugIn 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.
Golidocitinib
DrugIn 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.
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
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.
Complete Response Rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
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.
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
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