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Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma

NCT04961515 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-07-31

No results posted yet for this study

Summary

This phase II trial is evaluating the efficacy and side effect of orelabrutinib, sintilimab and temozolomide as possible treatments for relapsed or refractory central nervous system lymphoma.

Conditions

  • Primary Central Nervous System Hodgkin Lymphoma

Interventions

DRUG

Orelabrutinib

Orelabrutinib: 150 mg orally once daily

DRUG

Sintilimab

Sintilimab: 200 mg intravenously every 3 weeks

DRUG

Temozolomide (TMZ)

Temozolomide: 150 mg/m² orally on days 1-5 of each 21-day cycle

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Wenzhou Central Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Zhejiang Provincial Tongde Hospital

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Jinhua Central Hospital

    collaborator OTHER

  • Jinhua People's Hospital

    collaborator OTHER

  • Yinzhou Hospital Affiliated to Medical School of Ningbo University

    collaborator OTHER

  • Huzhou Central Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961515 on ClinicalTrials.gov