drugset / Trial / NCT04134247

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

NCT04134247

Phase 4 Unknown 120 enrolled Shandong Provincial Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-11-01
Primary completion
2021-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Background Cisplatin Other / unclassified 25 mg/m2
Background Cyclophosphamide Other / unclassified 750 mg/m2
Background Cytarabine Small molecule 2 g
Background Cytarabine Small molecule 3 g
Background Dexamethasone Small molecule 10 mg
Background Dexamethasone Small molecule 20 mg
Background Dexamethasone Small molecule 40 mg
Background Epirubicin Small molecule 15 mg/m2
Background Etoposide Small molecule 50 mg/m2
Background Etoposide Small molecule 60 mg/m2
Background Gemcitabine Small molecule 800 mg/m2
Background Gemcitabine Small molecule 1000 mg/m2
Background Ifosfamide Small molecule 1 g/kg
Background MTX Unknown 1 g
Background MTX Unknown 3.5 g
Background Oxaliplatin Small molecule 130 mg/m2
Background Prednisone Other / unclassified 60 mg/m2
Background Rituximab Monoclonal antibody 375 mg/m2
Background Vincristine Small molecule 0.4 mg/m2

Indications