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

February 8, 2025 updated by: Peking Union Medical College Hospital

A Single-arm, Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin (P-P-GEMOX) Regimen for Newly Diagnosed Extranodal NK/T-Cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P-P-GemOx arm
Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen
Drug: Immunochemotherapy

P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg/m2 iv D1, Oxaliplatin 100mg/m2 iv D1 This regimen is administered every 3 weeks.

For patients with stage I-II (localized) disease:

A sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiotherapy (IMRT). Following radiotherapy, an additional 2 cycles of the P-P-GemOx regimen are administered.

For patients with stage III-IV (advanced) disease. Patients are planned to receive 6 cycles of the P-P-GemOx regimen. For those achieving CR or PR following 6 cycles of immunochemotherapy, subsequent treatment options include autologous hematopoietic stem cell transplantation (auto-HSCT) or PD-1 monoclonal antibody maintenance therapy, determined based on age and overall physical condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
Treatment responses were assessed according to the 2014 Lugano classification criteria.
Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From date of enrollment until documented disease progression or death of any reason (up to 3 years).
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
From date of enrollment until documented disease progression or death of any reason (up to 3 years).
Overall survival
Time Frame: From date of enrollment until documented death of any reason (up to 3 years).
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
From date of enrollment until documented death of any reason (up to 3 years).
Overall response rate
Time Frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).
The ORR was defined as the proportion of patients with CR or PR.
Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).
Adverse event
Time Frame: From enrollment till 28 days post the last induction cycle.
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
From enrollment till 28 days post the last induction cycle.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2024

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NHL-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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