Clinical trial NCT04338282: Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma
Official title: Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: extranodal NK/T-cell lymphoma
PD-1 blockade
maintenance therapy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For patients with positive plasma EBV-DNA at the end of treatments, anti-PD-1 antibody (toripalimab 240mg, every 3 weeks for up to one year)is given as maintenance therapy for 1 year.
Primary purpose: TREATMENT

Brief summary: For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.

Detailed description: For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.

Eligibility criteria: Inclusion Criteria:

* Pathology confirmed diagnosis of NK/T-cell lymphoma.
* Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
* ECOG score of 0-3 points.
* The lab tests within 1 week before enrollment meets the following:

  * Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
  * Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
  * Renal function: Cr is normal.
  * Coagulation: plasma fibrinogen≥1.0g/L.
  * Cardiac function: LVEF≥50%, ECG is normal
* Sign the informed consent form.
* Voluntary compliance with research protocols.

Exclusion Criteria:

* Patients had relapsed NK/T-cell lymphoma.
* Active infection requires ICU treatment.
* Concomitant HIV infection or active infection with HBV, HCV.
* Serious complications such as fulminant DIC.
* Significant organ dysfunction:

  * respiratory failure
  * NYHA classification≥2 chronic congestive heart failure
  * decompensation Hepatic or renal insufficiency
  * high blood pressure and diabetes that cannot be controlled
  * cerebral vascular events within the past 6 months.
* Pregnant and lactating women.
* Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require treatments within 6 months.
* Other experimental drugs are being used.

Primary outcomes:
measure: one-year progression free survival rate
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes:
measure: one-year overall survival rate
timeFrame: From date of enrollment until the date of documented death from any cause or last follow up, whichever came first, assessed up to 12 months
measure: negative conversion rate of plasma EBV-DNA
timeFrame: up to one year
Other outcomes:
Locations:
Study officials:
References:
citation: Wang L, Wang H, Wang JH, Xia ZJ, Lu Y, Huang HQ, Jiang WQ, Zhang YJ. Post-treatment plasma EBV-DNA positivity predicts early relapse and poor prognosis for patients with extranodal NK/T cell lymphoma in the era of asparaginase. Oncotarget. 2015 Oct 6;6(30):30317-26. doi: 10.18632/oncotarget.4505.