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

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

This study is testing a new combination of two drugs, linperlisib and chidamide, to see if they can help people with relapsed cutaneous T-cell lymphoma feel better when other treatments haven't worked.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06037239 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of combining the HDAC inhibitor chidamide with the PI3K inhibitor linperlisib in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). It targets individuals aged 18-75 who have confirmed mycosis fungoides or Sezary syndrome and measurable lesions. Participants must have experienced no remission or relapse after at least one systemic therapy. The study is conducted at a single center, Peking Union Medical College Hospital, and aims to provide insights into a potentially effective treatment combination for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed mycosis fungoides or Sezary syndrome and measurable lesions who have not responded to previous systemic therapies.

Not a fit: Patients with acute myocardial infarction, uncontrolled infections, or active hepatitis B and C infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could offer a new therapeutic option for patients with difficult-to-treat cutaneous T-cell lymphoma.

How similar studies have performed: While the combination of these agents has shown promise in other studies, this specific approach is being explored for the first time in this patient population.

Eligibility criteria

Inclusion Criteria:

* Ages 18-75;
* Mycosis fungoides and Sezary syndrome confirmed by histopathology;
* Patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage IIB-IVB;
* No remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.);
* 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\<2.5UNL, TBil\<1.5ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);

Exclusion Criteria:

* 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;
* Investigators judged that they were not suitable to participate in the study

Where this trial is running

Beijing, Beijing

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

Study contacts

• Study coordinator: Wei Zhang

Conditions Cutaneous T-cell Lymphoma