Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
Plain-language summary
This trial is testing chidamide (HDAC inhibitor) combined with azacitidine and other agents for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment as well as those who have responded to prior therapy and may receive maintenance treatment. The study looks at both safety and how well the treatment controls the lymphoma. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.
Who can join (key eligibility)
- Age 18 Years or older
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
SCA Induction followed by Response-Adapted Therapy (DRUG): Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 \[SCA\]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen. Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin). Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy).
SCA Induction followed by Response-Adapted Therapy
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details