RecruitingPhase 1Phase 2NCT05949944

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma:a Single-Arm, Open Lable, Multicenter Clinical Trial(LINCH Study)


Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Aug 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called linperlisib combined with standard CHOP chemotherapy as a first treatment for a group of blood cancers called peripheral T-cell lymphomas (PTCL). Researchers want to see if this combination is safe and more effective than standard treatment alone. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with certain types of PTCL (including PTCL-NOS, AITL, enteropathy-related, or hepatosplenic T-cell lymphoma) - You have not received any previous anti-cancer treatment - You have at least one measurable area of cancer visible on scans - Your overall health and organ function are adequate - You do not have hemophagocytic syndrome (a serious immune reaction) **You may NOT be eligible if...** - You have previously taken a PI3K inhibitor drug - Your lymphoma has spread to the brain or spinal fluid - You have active hepatitis B or C infection - You have uncontrolled high blood pressure, serious heart disease, or severe lung disease - You have active HIV infection or a history of organ transplantation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinperlisib in combination with CHOP

Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months.


Locations(1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT05949944


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