Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCA Induction followed by Response-Adapted Therapy.
- Who it may be relevant to
- Registry conditions: Complete Remission Rate， CRR, Progression Free Survival, Overall Survival, Adverse Event. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer/T-Cell Lymphoma (SCENT-3)
Overview
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).
Interventions
- Drug SCA Induction followed by Response-Adapted Therapy
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 achievi
Primary outcome measures
- Complete Remission rate [Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]
Secondary outcome measures (6)
- objective response rate [Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]
- Partial Remission (PR) rate [Time frame: From Baseline to the End of Systemic Treatment or the completion of 6 cycles (each cycle is 21 days), whichever occurs first.]
- Progression-Free Survival [Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
- Duration of Response [Time frame: From date of first documented response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
- Overall Survival [Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
- Adverse Events [Time frame: From the date of informed consent and first dose of study drug up to 30 days (or 90 days for immune-related AEs) after the last dose of study treatment or completion of radiotherapy.]
Eligibility criteria
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07542912 · SCENT-3