Combining linperlisib and chidamide for treating peripheral T-cell lymphoma
PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
This study is testing a new combination of two drugs, linperlisib and chidamide, to see if it can help people with peripheral T-cell lymphoma more than the usual chemotherapy treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Zhengzhou, Henan and 5 other locations) |
| Trial ID | NCT06421948 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma.
Not a fit: Patients with anaplastic large cell lymphoma or NK/T-cell lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could offer a more effective treatment option for patients with peripheral T-cell lymphoma.
How similar studies have performed: Other studies have shown promise in using combination therapies for lymphoma, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zhengzhou, Henan and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.