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

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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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

objective response rate


Condition

NK/T-cell Lymphoma

Intervention

SHR1210

Study Arms / Comparison Groups

 SHR1210 +Apatinib
Description:  SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

61

Start Date

October 20, 2018

Completion Date

June 30, 2021

Primary Completion Date

March 30, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Yuqin Song, +13683398726, [email protected]



Administrative Informations


NCT ID

NCT03701022

Organization ID

SHR-1210-APTN-IIT-NKT lymphoma


Responsible Party

Principal Investigator

Study Sponsor

Peking University


Study Sponsor

Yuqin Song, Principal Investigator, Cancer Hospital of Beijing University


Verification Date

October 2018