Combination treatment of sintilimab and linperlisib for relapsed NK/T-cell lymphoma
Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)
This study is testing a new combination of two drugs, sintilimab and linperlisib, to see if it can help people with relapsed NK/T-cell lymphoma who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, sintilimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06793956 on ClinicalTrials.gov |
What this trial studies
This open-label, phase Ib study evaluates the effectiveness of combining sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL). The trial aims to determine the safety and efficacy of this combination treatment in individuals who have not responded to previous therapies. Participants must have a confirmed diagnosis of NKTCL and meet specific eligibility criteria, including having measurable lesions and adequate organ function. The study is designed to provide insights into a potential new treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed relapsed or refractory NKTCL after prior treatment failure.
Not a fit: Patients with a history of aggressive NK-cell leukemia or those who have previously been treated with PI3K inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with relapsed or refractory NKTCL.
How similar studies have performed: While this approach is novel in the context of NKTCL, similar combination therapies have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Universitiy Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.