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

Primary Purpose

Extranodal NK/T-cell Lymphoma, Nasal Type

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
toripalimab
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment arm

    Arm Description

    anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    one-year overall survival rate
    overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first
    negative conversion rate of plasma EBV-DNA
    plasma EBV-DNA status converted from positive to negative

    Full Information

    First Posted
    April 6, 2020
    Last Updated
    April 6, 2020
    Sponsor
    Beijing Tongren Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04338282
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    May 31, 2022 (Anticipated)
    Study Completion Date
    May 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Tongren Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extranodal NK/T-cell Lymphoma, Nasal Type
    Keywords
    extranodal NK/T-cell lymphoma, PD-1 blockade, maintenance therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment arm
    Arm Type
    Experimental
    Arm Description
    anti-PD-1 antibody (toripalimab) 240mg/d, every 3 weeks, for up to one year or until disease progression.
    Intervention Type
    Drug
    Intervention Name(s)
    toripalimab
    Other Intervention Name(s)
    anti-PD-1-antibody
    Intervention Description
    240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first
    Primary Outcome Measure Information:
    Title
    one-year progression free survival rate
    Description
    progression free survival is caculated from date of study enrollment to documented disease progression or death of any reason, whichever came first
    Time Frame
    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 Outcome Measure Information:
    Title
    one-year overall survival rate
    Description
    overall survival is caculated from date of study enrollment to documented death of any reason or last follow up, whichever came first
    Time Frame
    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
    Title
    negative conversion rate of plasma EBV-DNA
    Description
    plasma EBV-DNA status converted from positive to negative
    Time Frame
    up to one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    LIANG WANG, M.D.
    Phone
    +8615013009093
    Email
    wangliangtrhos@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26210287
    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.
    Results Reference
    result

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

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