Recruiting NCT06793956
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sintilimab and Linperlisib Combination Treatment.
- Who it may be relevant to
- Registry conditions: Extranodal Natural Killer/T Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)
Overview
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).
Interventions
- Drug Sintilimab and Linperlisib Combination Treatment
Sintilimab administered via intravenous infusion; Linperlisib administered orally.
Primary outcome measures
- DLT [Time frame: Cycle 1 (21 days)]
- RP2D [Time frame: Cycle 1 (21 days)]
Secondary outcome measures (4)
- Objective response rate (ORR) [Time frame: Up to 24 weeks]
- AE and SAE [Time frame: Up to 24 weeks]
- 2-year Progression-free survival(PFS) [Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
- 2-year Overall survival(OS) [Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
Eligibility criteria
Inclusion criteria
- Pathologically confirmed extranodal NKTCL.
- Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
- Age ≥ 18 years.
- Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
- ECOG performance status: 0-2.
- Estimated survival time ≥ 3 months.
- At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
- Adequate organ and bone marrow function.
Exclusion criteria
- Patients previously treated with PI3K inhibitors.
- Patients with hemophagocytic syndrome.
- Patients known to be allergic to any component of monoclonal antibodies.
- Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
- Patients with aggressive NK-cell leukemia or central nervous system involvement.
- Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.
- Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.
- Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Universitiy Cancer Center — Guangzhou
Identifiers
NCT: NCT06793956 · B2024-753