drugset / Trial / NCT03346642

Two Stage Study of Combination of Chemotherapy, SHR-1210 and/or Decitabine for Relapsed/Refractory PMBCLs

NCT03346642

Phase 1/2 Unknown 30 enrolled Chinese PLA General Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a two stage, Phase I/II clinical trial for patients with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL). In the first stage, the participants will receive GVD (Gemcitabine, Vinorelbine and Doxorubicine) chemotherapy and PD-1 antibody (SHR-1210) treatment. The safety and efficacy of combined regimen will be evaluated. If deemed safe and efficacious, the investigators will proceed to the second stage of the study. In the second stage, the participants will receive GVD chemotherapy and SHR-1210 treatment with low-dose Decitabine priming. The safety and feasibility of combined regimens will be evaluated in phase I study. The feasibility will be accessed.

Timeline

Start
2017-05-01
Primary completion
2019-03-01
Completion
2019-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody
Subject Decitabine Small molecule
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Vinorelbine Small molecule 30 mg Intravenous