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Thiotepa, Pirtobrutinib, and Sintilimab for Frail or R/R CNS Lymphoma
NCT07416890Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- Zhejiang Cancer Hospital
- Modality
- Small Molecules, Monoclonal Antibodies
- Conditions
- central nervous system lymphoma
01
Overview
Phase 2, open-label, single-arm trial of pirtobrutinib, sintilimab and thiotepa in central nervous system lymphoma, sponsored by Zhejiang Cancer Hospital. Primary endpoint: Objective Response Rate. Started Feb 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Thiotepa, Pirtobrutinib , Sintilimab
Single experimental arm receiving induction with TPS followed by optional maintenance with pirtobrutinib and sintilimab.
03
Who it enrols
Adult patients with relapsed/refractory primary or secondary CNS lymphoma of B-cell lineage, unfit for high-dose methotrexate, with KPS >= 40 and adequate organ function. Excludes patients with active autoimmune diseases, active infections, or recent major surgery.
04
Endpoints
Primary
Objective Response Rate
Secondary
Complete Response Rate
Partial Response Rate
Progression-Free Survival
Overall Survival
Adverse Events
Serious Adverse Events
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