Actively Recruiting
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
Led by Sun Yat-sen University · Updated on 2025-03-13
12
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
CONDITIONS
Official Title
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed extranodal natural killer/T-cell lymphoma (NKTCL).
- Age 18 years or older.
- Relapsed or refractory NKTCL after at least one line of asparaginase-based chemotherapy or chemoradiotherapy.
- ECOG performance status between 0 and 2.
- Estimated survival time of 3 months or more.
- At least one measurable lesion according to Lugano 2014 lymphoma criteria.
- Adequate organ and bone marrow function.
- Voluntary participation with signed informed consent and full understanding of the study.
You will not qualify if you...
- Previous treatment with PI3K inhibitors.
- Presence of hemophagocytic syndrome.
- Known allergy to any component of monoclonal antibodies.
- History of other malignancies within 5 years or concurrent malignancies, except basal cell carcinoma of the skin.
- Diagnosis of aggressive NK-cell leukemia or central nervous system involvement.
- Participation in other drug clinical trials or anti-tumor treatment within 4 weeks before study start.
- Clinically significant gastrointestinal issues affecting drug intake or absorption, or history of total gastrectomy.
- History of interstitial lung disease, except asymptomatic cases caused by radiotherapy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, China, 51000
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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