Combining linperlisib and chidamide for treating peripheral T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine the maximum tolerated dose of the PI3Kδ inhibitor linperlisib when combined with the HDAC inhibitor chidamide in patients with peripheral T-cell lymphoma (PTCL). The study consists of a phase Ib trial where participants will receive a fixed dose of chidamide alongside escalating doses of linperlisib to identify the optimal dosage. Following this, a phase II trial will randomize newly diagnosed PTCL patients to receive either the combination treatment or the standard CHOP chemotherapy regimen. Efficacy assessments will be conducted after three cycles of treatment to evaluate the response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
* ECOG PS 0-2 at protocol entry
* Estimated life expectancy of 6 months or longer
* Measurable disease
* Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
* Written informed consent

Exclusion Criteria:

* Patients previously treated with PI3K inhibitor
* Patients previously treated with chidamide (phase Ib study is not limited by this item)
* Suspected or documented central nervous system involvement by lymphoma
* Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
* Patients with active, uncontrolled infections
* Unwillingness or inability to comply with the protocol
* Deemed 'unfit' by the treating physician
* Pregnant and/or breastfeeding women
* Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
* Patients with contraindications to chemotherapy
* Known hypersensitivity to one or more of the study drugs

Where it's running

• Affiliated Cancer Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Liling Zhang
  Wuhan, Hubei, China Recruiting
• Yajun Li
  Changsha, Hunan, China Recruiting
• Ming Jiang
  Chengdu, Sichuan, China Recruiting
• Huilai Zhang
  Tianjin, Tianjin Municipality, China Recruiting
• Cong Li
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yanyan Liu — A
• Study coordinator: Yanyan Liu
• Email: yyliu@zzu.edu.cn
• Phone: 86 037165587791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.