Combining linperlisib and chidamide for treating relapsed peripheral T-cell lymphoma

Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Peripheral T-cell Lymphoma: a Prospective, Multi-center Study

This study is testing if combining two drugs, linperlisib and chidamide, can help adults with relapsed peripheral T-cell lymphoma feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 2 sites (Beijing, Beijing/China and 1 other locations)
• Trial ID: NCT06083701 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of combining the HDAC inhibitor chidamide with the PI3K inhibitor linperlisib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The study aims to enroll adults aged 18-75 with pathologically confirmed PTCL and at least one measurable lesion. Participants will be monitored for treatment response and safety outcomes as part of a multi-center approach. The trial seeks to build on previous findings that suggest both drugs have shown clinical activity as monotherapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of various subtypes of PTCL who have experienced relapse or refractory disease.

Not a fit: Patients with extranodal natural killer/T cell lymphoma or those previously treated with PI3K inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with relapsed or refractory PTCL.

How similar studies have performed: Previous studies have shown promising results with similar combinations of HDAC and PI3K inhibitors in treating PTCL, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Ages 18-75;
* Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
* Fulfills the criteria for relapsed/refractory lymphoma;
* There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be \> 1.5cm, for measurable extranodal lesion, the longest diameter should be \> 1.0cm;
* ECOG score of 0-2;
* Adequate bone marrow hematopoietic function: neutrophil count (ANC)

  ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
* Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT\<3UNL, TBil\<2ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);

Exclusion Criteria:

* Extranodal natural killer/T cell lymphoma;
* Previously treated with PI3K inhibitors;
* Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (\> 450ms in men and \> 470ms in women) within 6 months;
* Uncontrolled active infections;
* Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded);
* Pregnant or lactating women;

Where this trial is running

Beijing, Beijing/China and 1 other locations

• Peking Union Medical College Hospital — Beijing, Beijing/China, China (RECRUITING)
• Beijing Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Daobin Zhou, Dr

Conditions: Peripheral T Cell Lymphoma