Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
Starting soon · Not applicable
Conditions studied: Complete Remission Rate， CRR, Progression Free Survival, Overall Survival, Adverse Event, Duration of Response
In brief
This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).
Key facts
- Study ID
- NCT07542912
- Run by
- Sun Yat-sen University
- People needed
- 30
- Starts
- 2026-06-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willingness to participate in the clinical study.
- Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- Newly diagnosed ENKTL confirmed by histopathology at the study center.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- At least one evaluable or measurable lesion
- Ann Arbor stage I-II disease.
- PINK-E score ≥ 1.
- Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or abnormalities in cardiac, pulmonary, hepatic, renal, or thyroid function, and no immunodeficiency.
You may not qualify if…
- Aggressive natural killer cell leukemia.
- Presence of hemophagocytic syndrome.
- Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Patients with active chronic hepatitis B or active hepatitis C.
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, China
Full record on ClinicalTrials.gov
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