NCT05491044

A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, multi-center study to evaluate the efficacy and safety of orelabrutinib for Chronic lymphocytic lymphoma（CLL)/small lymphocytic lymphoma (SLL) patients who are slowly responding to Ibrutinib switched to Orelabrutinib.

Detailed description

The eligible CLL/SLL patients who are slowly responding to Ibrutinib will be switched to Orelabrutinib treatment. The patients will receive Orelabrutinib 150mg oral daily (28 days/cycle) for up to 2 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).

Conditions

• CLL/SLL

Interventions

Type	Name	Description
DRUG	orelabrutinib	Orelabrutinib 150mg po qd d1-28, up to 2 years or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-08-28
• Completion: 2024-08-30
• First posted: 2022-08-08
• Last updated: 2023-10-26

Locations

2 sites across 1 country: China