Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma

Launched by SUN YAT-SEN UNIVERSITY · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment using two medications, sintilimab and linperlisib, for patients who have a type of blood cancer called extranodal natural killer/T-cell lymphoma (NKTCL) that has come back or hasn't responded to previous treatments. The trial is currently recruiting participants aged 18 and older who have been diagnosed with this specific cancer and have already tried at least one treatment that included asparaginase, which is a type of chemotherapy. To be eligible, participants should be in reasonably good health and have measurable signs of their disease.

If you join this study, you'll be closely monitored by healthcare professionals who will assess how well the treatment works and how well you tolerate it. This is an open-label study, meaning both you and the researchers will know which medications you're receiving. Your participation will help researchers learn more about this treatment combination and its potential benefits for people with relapsed or refractory NKTCL. It's important to note that some people may not be eligible for this trial, especially those who have specific health issues or have received certain treatments recently.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Pathologically confirmed extranodal NKTCL.
• • 2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
• • 3. Age ≥ 18 years.
• • 4. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
• • 5. ECOG performance status: 0-2.
• • 6. Estimated survival time ≥ 3 months.
• • 7. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
• • 8. Adequate organ and bone marrow function.
• Key Exclusion Criteria:
• • 1. Patients previously treated with PI3K inhibitors.
• • 2. Patients with hemophagocytic syndrome.
• • 3. Patients known to be allergic to any component of monoclonal antibodies.
• • 4. Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
• • 5. Patients with aggressive NK-cell leukemia or central nervous system involvement.
• • 6. 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.
• • 7. 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.
• • 8. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).