Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma

Summary

This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

DRUG

orelabrutinib

Orelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

DRUG

Sintilimab

Sintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

DRUG

Tislelizumab

Tislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

Sponsors & Collaborators

• Beijing Hospital

  collaborator OTHER_GOV

• Beijing Tongren Hospital

  collaborator OTHER

• Beijing Luhe Hospital

  collaborator OTHER

• Shanxi Province Renmin Hospital

  collaborator UNKNOWN

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Henan Province Renmin Hospital

  collaborator UNKNOWN

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• The First Hospital of Chinese Medical University

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Hospital of Zhengzhou University

  collaborator UNKNOWN

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-24

Primary Completion

2023-03-24

Completion

2023-10-24

Countries

• China

Study Locations