Skip to content
TrialMatch
Sign up
Recruiting Phase 1 / Phase 2

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, T-lymphoblastic Lymphoma
Tested
Linperlisib, Camrelizumab, Pegaspargase, Dexamethasone
Sponsor
Beijing Tongren Hospital

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, T-lymphoblastic Lymphoma
  • 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 11

  • 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

1 site, 1 recruiting

Liang Wang

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.