Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Recruiting
Phase 1Phase 2Interventional Study
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeT-lymphoblastic Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
43 (estimated)
Sponsor
Beijing Tongren Hospital · Other
Who this trial is looking for
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The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.
Trial Locations
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Eligibility Criteria
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 su…
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.
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