Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma (NCT07542912) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
China30 participantsStarted 2026-06-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Aggressive natural killer cell leukemia.
✕. Presence of hemophagocytic syndrome.
What they're measuring
1
Complete Remission rate
Timeframe: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.