RecruitingPhase 2NCT04961515

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

A Phase II Study of Orelabrutinib, Sintilimab and Temozolomide in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

19 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — orelabrutinib, sintilimab (an immunotherapy), and temozolomide (chemotherapy) — for people whose lymphoma in the brain has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with primary central nervous system (CNS) lymphoma or diffuse large B-cell lymphoma (DLBCL) that has spread only to the brain or spinal cord - Your lymphoma has returned or is not responding to prior treatment - You have received at least one prior treatment that included methotrexate - You are 18 years or older - You are able to follow the study schedule and complete required tests **You may NOT be eligible if...** - Your lymphoma has spread outside the brain and spinal cord - You have not previously received methotrexate-based treatment - You have serious medical conditions that would make participation unsafe - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orelabrutinib: 150 mg orally once daily

DRUGSintilimab

Sintilimab: 200 mg intravenously every 3 weeks

DRUGTemozolomide (TMZ)

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


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT04961515