Trial Title:
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
NCT ID:
NCT06376721
Condition:
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
T-lymphoblastic Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Dexamethasone
Dexamethasone acetate
Pegaspargase
Asparaginase
BB 1101
Conditions: Keywords:
r/r ENKTL
Linperlisib
PD-1 blockade
Pegaspargase
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced
or relapsed/refractory ENKTCL patients
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Linperlisib
Description:
Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
Arm group label:
treatment arm
Other name:
YY-20394
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab for Injection: 200 mg/d, intravenous drip for 30 min (not less than 20 min
and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours
after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing
may be administered up to 5 days before or after the day of the scheduled dosing; more
than 3 days after the date of the scheduled dosing will be considered a delayed dosing.
Arm group label:
treatment arm
Other name:
Camrelizumab for Injection
Intervention type:
Drug
Intervention name:
Pegaspargase
Description:
Pegaspargase: 2500 IU/m2, intramuscular injection, divided into three places,
administered on the first day of each cycle, observed 2 hours after injection for the
occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving
other test drugs. Every 3 weeks as a dosing cycle.
Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Arm group label:
treatment arm
Other name:
Pegaspargase injection
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the
same day as Dexamethasonee.
Arm group label:
treatment arm
Other name:
Dexamethasone oral
Summary:
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.
Detailed description:
This is a prospective, single-arm, single-center Ib/II clinical trial that included an
initial safety run-in phase with safety monitoring before the main enrollment (expansion
phase).The aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting
toxicity (DLT), and the aim of phase II study is to evaluate, for the first time, the
safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade
Camrelizumab and Pegaspargase in patients diagnosed with advanced or r/r ENKTL,
respectively.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liang Wang
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Wang, M.D.
Phone:
+8615001108693
Email:
wangliangtrhos@126.com
Investigator:
Last name:
Liang Wang, M.D.
Email:
Principal Investigator
Start date:
April 14, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Source:
Beijing Tongren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376721
