Clinical trial · Interventional

Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma

Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma: a Single Arm, Single Center, Open Label, Phase 2 Trial

NCT04338282CI-TRIAL-00044544unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Extranodal NK/T-cell Lymphoma, Nasal Type	Extranodal NK-/T-Cell Lymphoma, Nasal Type	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
toripalimab	Drug	Toripalimab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
treatment arm
description
anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.
interventionNames
1. Drug: toripalimab

Primary outcomes (1)

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
description
progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first

Secondary outcomes (2)

measure
one-year overall survival rate
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (1)

RESULTWang 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. PMID 26210287