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

NCT03701022 | Unknown Phase 2

• 1 other identifier: SHR-1210-APTN-IIT-NKT lymphoma
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• objective response rate

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

  from first patient first visit to 6 month after last patient first visit

Study Arms (1)

SHR1210 +Apatinib

EXPERIMENTAL

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

Drug: SHR1210

Interventions

SHR1210 DRUG

SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day.

Also known as: Apatinib

SHR1210 +Apatinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yuqin Song

  Cancer Hospital of Beijing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqin Song

CONTACT

+13683398726; songyuqin622@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Party secretary of Cancer Hospital of Peking University，Director of Internal Medicine

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: October 20, 2018
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share