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Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma

ConditionNatural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination.

Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE/IIE based on PET/CT and bone marrow examination according to the Lugano 2014 criteria.

Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET/CT.

No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma.

Disqualifiers

Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA >10^3/ml.

Patients with a history of pancreatitis.

Patients with acute or systemic infections requiring intravenous antibiotic therapy.

Patients with severe complications such as hemophagocytic syndrome, DIC, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab+Pegaspargase

    Drug

    1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1;

  • P-GemOx

    Drug

    1. pegaspargase 2000U/m\^2, capped at 3750U on day 1, intramuscular; 2. gemcitabine 1.0g/m\^2 on day 1 and day 8, intravenous drip; 3. oxaliplatin 130mg/m\^2 on day 1, intravenous drip

  • GELAD

    Drug

    1. gemcitabine 1.0g/m\^2 on day 1, intravenous drip; 2. etoposide 60mg/m\^2 on day 1-3, intravenous drip; 3. pegaspargase 2000U/m\^2, capped at 3750U on day 1,intramuscular; 4. dexamethasone 20mg on day 1-4, intravenous drip.

  • IMRT

    Radiation

    Intensity modulated radiotherapy (50-56Gy)

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Group A (synchronous treatment group)Experimental treatment 2 interventions
Group B: Group B (sequential treatment group)Experimental treatment 2 interventions
Group C: Group C (sandwiched radiotherapy group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PFS24

Rate of patients with 24-month progression-free survival

Time frame
From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.

Secondary outcomes

1

ORR

Overall response rate

Time frame
response rate at 24th week
2

OS

Overall survival

Time frame
From the time of patient randomization to the end of study, assessed up to 60 months
3

EFS

Event-free survival

Time frame
From the time of patient randomization to the end of study, assessed up to 60 months
4

TRAE

Treatment-related adverse event related to the study drug or intervention

Time frame
From the time of patient randomization to the end of study, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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