Status:
UNKNOWN
Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With RR NHL
Lead Sponsor:
Shandong Provincial Hospital
Conditions:
Relapsed/Refractory Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (NHL) is highly heterogeneous and can be broadly divided into two ma...
Detailed Description
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. In recent years, the incidence of malignant lymphoma in China has increased rapidly. It has...
Eligibility Criteria
Inclusion
- Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression.
- A recurrent or refractory disease defined as: 1) recurrence of disease after complete remission (CR); or 2) partial remission (PR), disease stabilization (SD), or disease Progress (PD) when the treatment is completed prior to enrollment in the study.
- Age≥18 years old, both men and women.
- The ECOG score is 0-2.
- There is at least one evaluable lesion (maximum diameter\>15mm or shortest diameter\>10mm). Preferably, PET-CT shows high metabolism of FDG.
- Have received appropriate first-line and more-line treatment of the corresponding NHL.
- Liver and kidney function: blood bilirubin≤35μmol/L, AST or ALT is less than 2 times the upper limit of normal value, serum creatinine≤150μmol/L.
- The thyroid function is normal.
- Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment.
- Subjects must sign an informed consent form.
Exclusion
- Age\<18 years old；
- Received ASCT within 90 days prior to the first use of the study drug;
- Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;
- Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;
- Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4
- Exposure to any study drug within 4 weeks prior to the first use of the study drug
- Expose to the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy or arterial embolization) within 3 weeks prior to the first use of the study drug.
- Have a history of oncology and have received any treatment for this tumor in the past 3 years;
- Patients during pregnancy and lactation;
- Accompanied by severe heart disease, including acute myocardial infarction within 6 months, or in accordance with New York Heart Association cardiac function III or IV;
- A serological test for HIV or active hepatitis C virus is known to be positive;
- Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known;
- TB patients active period
- Other circumstances that the investigator believes are not suitable for inclusion.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04134247
Start Date
November 1 2019
End Date
November 1 2021
Last Update
October 22 2019
Active Locations (1)
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1
Department of Hematology, Shandong Provincial Hospital
Jinan, Shandong, China, 250012