Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With RR NHL

• Status: Unknown status
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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 major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.The anti-PD-1 antibody may benefit patients with relapsed or refractory Hodgkin's lymphoma. At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. We propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Non-Hodgkin's lymphoma (NHL) confirmed by histopathology, preferably in the detection of tumor tissue PD-L1 expression.

2. 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.

3. Age≥18 years old, both men and women.

4. The ECOG score is 0-2.

5. There is at least one evaluable lesion (maximum diameter>15mm or shortest diameter>10mm). Preferably, PET-CT shows high metabolism of FDG.

6. Have received appropriate first-line and more-line treatment of the corresponding NHL.

7. 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.

8. The thyroid function is normal.

9. Women of childbearing age are required to undergo a pregnancy test before receiving treatment and must agree to take effective contraception during treatment.

10. Subjects must sign an informed consent form.

Exclusion Criteria:

1. Age<18 years old；

2. Received ASCT within 90 days prior to the first use of the study drug;

3. Severe allergies, or patients known to be allergic or intolerant of the drug components of the chemotherapy regimen;

4. Active, unrecognized or suspected autoimmune disease, or a history of autoimmune disease within 2 years;

5. Previously exposed to any antibody against PD-1, PD-L1 or cytotoxic T lymphocyte-associated antigen 4

6. Exposure to any study drug within 4 weeks prior to the first use of the study drug

7. 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.

8. Have a history of oncology and have received any treatment for this tumor in the past 3 years;

9. Patients during pregnancy and lactation;

10. 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;

11. A serological test for HIV or active hepatitis C virus is known to be positive;

12. Hepatitis B virus carriers or hepatitis B virus DNA positive untreated patients are known;

13. TB patients active period

14. Other circumstances that the investigator believes are not suitable for inclusion.