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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Tazemetostat
  • Linperlisib
  • Golidocitinib

Treatment groups

48 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators