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OncoMatch/Clinical Trials/NCT06824883

Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

Is NCT06824883 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Immunochemotherapy for extranodal nk/t-cell lymphoma.

Phase 2RecruitingPeking Union Medical College HospitalNCT06824883Data as of Jun 2026Location: China

Treatment: ImmunochemotherapyThis 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.

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Extracted eligibility criteria

Treatments studied

Other

Immunochemotherapy

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–3(Limited self-care)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

ANC ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L with bone marrow involvement); PLT ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L with bone marrow involvement); HGB ≥ 80 g/L

Kidney function

Serum creatinine < 1.5 × ULN

Liver function

ALT < 3 × ULN; TBil < 1.5 × ULN

Cardiac function

NYHA heart function class 0-2; LVEF > 50%

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%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06824883 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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