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Clinical Trial Summary

This is a single arm, single center, open label pilot study of Orelabrutinib combined with Rituximab, high-dose (HD) Methotrexate and Dexamethasone in newly-diagnosed primary central nervous system lymphpoma (PCNSL). The purpose is to evaluate the safety and to find the optimal dose of Orelabrutinib in this combination treatment for newly-diagnosed PCNSL patients.


Clinical Trial Description

The eligible patients will be treated with Orelabrutinib combined with Rituximab, high-dose Methotrexate and Dexamethasone during induction treatment (6 cycles; 21 days/cycle): Rituximab 375 mg/m2, intravenous infusion, d1; HD-MTX 3.5 g/m2 intravenous infusion (3h), d2; Dexamethasone 10-15 mg, iv, d2-4. Orelabrutinib will be given 72h after MTX infusion or until MTX clearance. Orelabrutinib dose escalation will follow the "3+3" design. The starting dose of Orelabrutinib is 150 mg/d and the dose will be escalated to 200 mg/d, throughout the whole cycle. For CR/CRu patients after completion of induction treatment, daily Orelabrutinib will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first). Patients will be evaluated every 2 cycles during induction therapy and every 12 weeks during maintenance therapy. ;


Study Design


Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma

NCT number NCT05036577
Study type Interventional
Source Huashan Hospital
Contact Tong Chen
Phone +862152887102
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date October 8, 2021
Completion date September 30, 2023

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