Combination treatment for advanced NK/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 investigates the safety and efficacy of a combination therapy using Linperlisib, a PI3K-δ inhibitor, along with Camrelizumab, a PD-1 blockade, and Pegaspargase in patients with advanced or relapsed/refractory NK/T-cell lymphoma. The study is designed as a single-arm, single-center trial that includes an initial safety run-in phase followed by an expansion phase. The primary goals are to determine the recommended phase 2 dose and assess dose-limiting toxicity, as well as to evaluate the overall treatment effectiveness in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.
* refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* Expected to survive more than 3 months.
* General status ECOG score 0-2 points.
* The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: WBC≥3×10e9/L, PLT≥75×10e9/L, ANC≥1.5×10e9/L. sCR≤1.5 mg/dL,GFR≥50 ml/min. Liver function: ALT \& AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.

Serum fibrinogen level≥1.0 g/L.

•Sign the informed consent form

Exclusion Criteria:

* Patients with CNS involvement, or with other neoplasm;
* Patients has received PI3K inhibitor treatment before enrollment
* Poor performance status, ECOG≥2;
* Patients in lactation or pregnancy；
* Patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures；
* Patients allergic to any of the study drugs；
* Patients with active infection；
* Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
* Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia;
* Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past
* According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.

Where it's running

• Liang Wang
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Liang Wang, M.D. — Beijing Tongren Hospital
• Study coordinator: Liang Wang, M.D.
• Email: wangliangtrhos@126.com
• Phone: +861058268442

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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.