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New treatment option for Extranodal Natural Killer/T Cell Lymphoma
Official title Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
ClinicalTrials.gov ID: NCT06793956
What this study is testing
What is Sintilimab and Linperlisib Combination Treatment?
Sintilimab and Linperlisib Combination Treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extranodal natural killer/t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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. Key
- 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...
- Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.