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PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma

Primary Purpose

NK/T-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR1210
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NK/T-cell Lymphoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed extranodal NK/T cell lymphoma nasal, PTCL,NOS, AITL, ALCL;
  2. Subjects must be recurrent or refractory, and 10-15 white tumors of tumor tissue should be provided.
  3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
  4. ECOG performance status of 0 or 1;

6.Life expectancy ≥ 12 weeks.; 7.Adequate laboratory parameters during the screening period as evidenced by the following:

a.Absolute neutrophil count ≥ 1.5× 109/L ; b.Platelets ≥ 100 × 109/L; c.Hemoglobin ≥ 9.0 g/dL; d.Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN e.Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min; f.Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN 8.Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.

9.Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

  1. Known central nervous system lymphoma
  2. Haemophilus cell syndrome at diagnosis
  3. Large lung vessels were involved
  4. History and complication

    1. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
    2. Subjects requiring systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents were given the study drug within 14 days prior to administration. Inhaled or topical corticosteroids and adrenaline replacement at a therapeutic dose of more than 10 mg/day prednisone are allowed in the absence of active autoimmune disease
    3. Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
    4. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
    5. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
    6. Known and suspicion of interstitial pneumonia
    7. History of other malignancies except in patients with basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, or carcinoma of the cervix in situ who had undergone potential curable treatment and had no recurrence within five years of initiation of self-treatment;
    8. Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
    9. Prior allo-HSCT.
    10. ASCT within 90 days.
    11. Impact of major surgery or severe trauma had been eliminated for less than 14 days.
    12. Active pulmonary tuberculosis.
    13. Severe acute or chronic infection requiring systemic therapy.
    14. In the first 2 months before treatment, there was a significant amount of half a teaspoon (2.5ml) of blood or hemoptysis
    15. Significant clinical symptoms of bleeding or a clear tendency to bleed occurred within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc;
    16. Arteriovenous thrombotic events, such as cerebral vascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first six months of treatment.
    17. Known hereditary or acquired bleeding and thrombotic tendencies ;
    18. Suffering from hypertension, and the treatment of hypotensive drugs can not get good control.(systolic blood pressure is greater than 140 mmHg or diastolic pressure is more than 90 mmHg);
    19. Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months;
    20. Live vaccinations were given within four weeks before the study drug was administered. Inactivated viral vaccines for seasonal influenza were allowed, but live attenuated influenza vaccines for intranasal use were not allowed.
  5. laboratory test

    1. known HIV positive or known AIDS.
    2. Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
    3. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2G / L) having tends to bleed or is undergoing thrombolytic or anticoagulant therapy;
    4. Routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1 g.
  6. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
  7. Women suffering from pregnancy or lactation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHR1210 +Apatinib

    Arm Description

    SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.

    Outcomes

    Primary Outcome Measures

    objective response rate
    rate of subjects achieved complete response plus partial response in all evaluable subjects

    Secondary Outcome Measures

    Full Information

    First Posted
    October 7, 2018
    Last Updated
    October 7, 2018
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03701022
    Brief Title
    PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma
    Official Title
    An Open-lable, Single Arm, Single Center, Phase 2 Study of PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2018 (Anticipated)
    Primary Completion Date
    March 30, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University

    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
    This is an open-label, single-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 combined with Apatinib in subjects with relapsed or refractory NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
    Detailed Description
    The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 combined with Apatinib in patients with relapsed or refractory NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years,safety and immunogenicity of SHR-1210 combined with Apatinib in relapsed or refractory NK/T cell lymphoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NK/T-cell Lymphoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SHR1210 +Apatinib
    Arm Type
    Experimental
    Arm Description
    SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    SHR1210
    Other Intervention Name(s)
    Apatinib
    Intervention Description
    SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day.
    Primary Outcome Measure Information:
    Title
    objective response rate
    Description
    rate of subjects achieved complete response plus partial response in all evaluable subjects
    Time Frame
    from first patient first visit to 6 month after last patient first visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed extranodal NK/T cell lymphoma nasal, PTCL,NOS, AITL, ALCL; Subjects must be recurrent or refractory, and 10-15 white tumors of tumor tissue should be provided. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria ECOG performance status of 0 or 1; 6.Life expectancy ≥ 12 weeks.; 7.Adequate laboratory parameters during the screening period as evidenced by the following: a.Absolute neutrophil count ≥ 1.5× 109/L ; b.Platelets ≥ 100 × 109/L; c.Hemoglobin ≥ 9.0 g/dL; d.Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN e.Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min; f.Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN 8.Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment. 9.Able to understand and sign an informed consent form (ICF). Exclusion Criteria: Known central nervous system lymphoma Haemophilus cell syndrome at diagnosis Large lung vessels were involved History and complication Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted Subjects requiring systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents were given the study drug within 14 days prior to administration. Inhaled or topical corticosteroids and adrenaline replacement at a therapeutic dose of more than 10 mg/day prednisone are allowed in the absence of active autoimmune disease Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; Known and suspicion of interstitial pneumonia History of other malignancies except in patients with basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, or carcinoma of the cervix in situ who had undergone potential curable treatment and had no recurrence within five years of initiation of self-treatment; Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1. Prior allo-HSCT. ASCT within 90 days. Impact of major surgery or severe trauma had been eliminated for less than 14 days. Active pulmonary tuberculosis. Severe acute or chronic infection requiring systemic therapy. In the first 2 months before treatment, there was a significant amount of half a teaspoon (2.5ml) of blood or hemoptysis Significant clinical symptoms of bleeding or a clear tendency to bleed occurred within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc; Arteriovenous thrombotic events, such as cerebral vascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first six months of treatment. Known hereditary or acquired bleeding and thrombotic tendencies ; Suffering from hypertension, and the treatment of hypotensive drugs can not get good control.(systolic blood pressure is greater than 140 mmHg or diastolic pressure is more than 90 mmHg); Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months; Live vaccinations were given within four weeks before the study drug was administered. Inactivated viral vaccines for seasonal influenza were allowed, but live attenuated influenza vaccines for intranasal use were not allowed. laboratory test known HIV positive or known AIDS. Untreated active hepatitis; Hepatitis B and hepatitis C infection in common. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2G / L) having tends to bleed or is undergoing thrombolytic or anticoagulant therapy; Routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1 g. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection Women suffering from pregnancy or lactation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuqin Song
    Phone
    +13683398726
    Email
    songyuqin622@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuqin Song
    Organizational Affiliation
    Cancer Hospital of Beijing University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma

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