Actively Recruiting
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-11-25
79
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
CONDITIONS
Official Title
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- Detectable measurable residual disease (MRD) in peripheral blood by flow cytometry
- On BTK inhibitor monotherapy (ibrutinib, zanubrutinib, orelabrutinib, or acalabrutinib) for more than 6 months
- At least partial response (PR) to BTK inhibitor monotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Adequate kidney and liver function as defined by specific lab value limits
- Adequate bone marrow function including platelet count, neutrophil count, and hemoglobin levels
- Adequate heart function with no uncontrolled heart rhythm problems, left ventricular ejection fraction (LVEF) of 35% or higher, and New York Heart Association (NYHA) class 2 or less
- Ability to give informed consent and comply with study follow-up
You will not qualify if you...
- Richter transformation
- Active cancers needing treatment other than CLL, except certain treated skin or cervical cancers
- Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks before study drug
- Serious bleeding events (grade 3 or 4 hemorrhage) within past 3 weeks
- Uncontrolled active infections
- Pregnant or breastfeeding females
- Known HIV infection
- Active hepatitis B infection with detectable virus; patients with certain hepatitis B markers but negative virus allowed with monthly monitoring
- Active hepatitis C infection
- Active uncontrolled autoimmune conditions requiring high dose steroids within 7 days before venetoclax
- Previous other CLL treatments during BTK inhibitor therapy before enrollment
- Use of warfarin or other oral anticoagulants
- Use of strong CYP3A inhibitors or inducers within 7 days before venetoclax
- Consumption of grapefruit, Seville oranges, or star fruit within 7 days before venetoclax
- Previous treatment with venetoclax or another Bcl-2 inhibitor
- Malabsorption or conditions preventing oral medication intake
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jianyong Li, PhD, MD
CONTACT
H
Huayuan Zhu, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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