NCT06824883 Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
| NCT ID | NCT06824883 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Extranodal NK/T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 49 participants in total. It began in 2024-05-20 with a primary completion date of 2026-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.
Eligibility Criteria
Inclusion Criteria: * Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center. * Age between 18 and 75 years. * At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA \> 500 copies/mL. * ECOG performance status of 0 to 3. * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g/L. * Adequate organ function: Alanine aminotransferase (ALT) \< 3 × the upper limit of normal (ULN); Total bilirubin (TBil) \< 1.5 × ULN; Serum creatinine \< 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) \> 50%. Exclusion Criteria: * Aggressive NK-cell leukemia. * Central nervous system lymphoma. * History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) \> 480 ms. * Uncontrolled active infection. * Pregnant or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06824883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Extranodal NK/T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06824883 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06824883 currently recruiting?
Yes, NCT06824883 is actively recruiting participants. Contact the research team at vv1223@vip.sina.com for enrollment information.
Where is the NCT06824883 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06824883 clinical trial?
NCT06824883 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 49 participants.