NCT04961515

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Orelabrutinib and anti-PD-1 monoclonal antibodies represent promising therapeutic classes for central nervous system lymphoma (CNSL). Given the poor outcomes and limited treatment options for relapsed or refractory CNSL, this study aims to evaluate the efficacy and toxicity of orelabrutinib combined with temozolomide and sintilimab in this population. Participants will receive fixed-dose orelabrutinib, sintilimab, and temozolomide for up to six 21-day cycles (induction phase), followed by sintilimab maintenance until disease progression (PD), intolerable toxicity, investigator/patient decision to withdraw, or a maximum treatment duration of 2 years (whichever occurs first). Tumor response will be assessed by MRI every two cycles during induction and every three months thereafter.

Conditions

• Primary Central Nervous System Hodgkin Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-07-14
• Last updated: 2025-07-31

Locations

1 site across 1 country: China