Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL/SLL

ConditionCLL/SLL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.

Eligibility criteria

Qualifiers

65 years of age and older or between 18 and 65 years of age with severe illness (non-CLL/SLL associated CIRS ≥ 6);

ECOG performance status (PS) level 0~2;

Expected survival is not less than 12 weeks;

Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or histopathology according to IWCLL2008 criteria, and CD20 positive;

Disqualifiers

Patients with 17P- chromosome abnormalities or TP53 mutations;

Current or previous biopsy pathology confirms conversion to Richter's syndrome;

Have active and uncontrolled autoimmune cytopenias, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;

Patients with central nervous system invasion;

Trial design

Treatments tested in this trial

  • Orelabrutinib and BG

Treatment groups

24 Participants
are divided into 1 treatment group