Reduced-intensity radiotherapy after chemo-induced remission for early-stage nasal NK/T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 trial evaluates reduced-intensity radiotherapy in adults with stage I-II, low-risk nasal-type NK/T-cell lymphoma who achieved complete remission after an asparaginase-based chemotherapy regimen. Eligible participants are 18 to 75 years old with PET-CT or MRI-confirmed disease and ECOG 0-1, and with 0-1 prognostic risk factors. The treatment focuses on delivering a lower-intensity radiotherapy course to assess safety and efficacy in maintaining remission. Primary endpoints typically include response durability and safety, with adverse events monitored per standard oncology criteria. The study is hosted at Ruijin Hospital in Shanghai, with Ruijin Hospital as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The patient voluntarily agrees to participate in this study and signs the informed consent form.
* Age ≥ 18 years and ≤ 75 years.
* Pathologically confirmed diagnosis of nasal-type NK/T-cell lymphoma.
* Clinical stage I-II disease confirmed by PET-CT or MRI.
* The lymphoma has been treated with an asparaginase-based chemotherapy regimen.
* Presence of 0-1 prognostic risk factors (risk factors: age \> 60 years, ECOG score ≥ 2, elevated LDH, elevated PTI, stage II).
* Imaging assessment shows complete clinical remission after chemotherapy.
* ECOG-PS score of 0-1.
* Expected survival of ≥ 12 months.
* Normal function of major organs, meeting the following criteria:

  1. Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 80 × 10⁹/L; hemoglobin ≥ 80 g/L.
  2. Biochemistry: total bilirubin \< 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance \> 50 mL/min.
* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use highly effective contraception during the study period and for 120 days after the last dose. For male subjects with female partners of childbearing potential, they must be surgically sterile or agree to use highly effective contraception during the study period and for 120 days after the last dose.

Exclusion Criteria:

* A previous or concurrent diagnosis of another malignancy, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
* Presence of severe medical conditions, or concomitant diseases or situations that may affect the patient's eligibility for enrollment or compromise safety during the study period.
* Pregnant or breastfeeding women.
* Presence of active mental disorders or other psychiatric conditions that may affect the patient's ability to sign the informed consent form or to comprehend the study information.
* Patients deemed by the investigator to have poor compliance.
* Distant metastasis confirmed by pathology or imaging.
* As judged by the investigator, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant treatment, significant laboratory abnormalities, or family or social factors that could compromise patient safety.

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Gang Cai, MD — Ruijin Hospital
• Study coordinator: Shu-Bei Wang, MD
• Email: wangshubei@163.com
• Phone: +86-021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.