Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

April 15, 2022

Primary Completion Date

February 22, 2025

Study Completion Date

November 5, 2025

Conditions
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Interventions
DRUG

Orelabrutinib

150 mg capsules administered orally once daily (28-day cycles). Until 12 or 24 cycles and following BM undetectable MRD, or disease progression, or intolerant toxicity.

DRUG

Obinutuzumab

1000 mg administered intravenously once on Day 1, 8, 15 of first cycle and on Day 1 of following cycles for maximal 12 cycles (28-day cycles).

DRUG

Fludarabine

25mg/m2/day administered intravenously on Day 1-3 for every cycle (at most 6 cycles, 28-day cycles).

DRUG

Cyclophosphamide

250mg/m2/day administered intravenously on Day 1-3 for every cycle (at most 6 cycles, 28-day cycles).

Trial Locations (1)

210029

RECRUITING

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER