Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy (NCT06958705) | Clinical Trial Compass
RecruitingPhase 2
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
China79 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age: 18-80 years-old.
* 2\. Patients must have a diagnosis of CLL/SLL.
* 3\. Detectable MRD by flow cytometry (10\^-4 sensitivity) in the peripheral blood.
* 4\. Patients who are on BTK inhibitor monotherapy for more than 6 months. This study includes patients who are taking one of the following BTK inhibitors: ibrutinib, zanubrutinib, orelabrutinib, and acalabrutinib.
* 5\. Patients need to have a response of at least PR (CR/PR) to BTK inhibitor monotherapy.
* 6\. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* 7\. Patients must have adequate renal and hepatic function:
* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;
* Serum creatinine clearance of ≥ 50 ml/min (calculated or measured);
* ALT and AST ≤ 3.0 × ULN, unless clearly due to disease involvement.
* 8\. Adequate bone marrow function:
* Platelet count of greater than 50,000/µl, with no platelet transfusion in prior 2 weeks;
* ANC ≥ 1000/µl in the absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by ≥ 80% CLL in marrow;
* Hemoglobin ≥ 8g/dL.
* 9\. Adequate cardiac function, as assessed by:
* Absence of uncontrolled cardiac arrhythmia;
* Echocardiogram demonstrating LVEF ≥ 35%;
* NYHA functional class ≤ 2.
* 10\. Ability to provide informed consent and adhere to the required follow-up.
Exclusion Criteria:
* 1\. Richter transformation.
* 2\. Active malignancy requirin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16)
Timeframe: On Day 1 of Cycle 16 (each cycle is 28 days)
Trial details
NCT IDNCT06958705
SponsorThe First Affiliated Hospital with Nanjing Medical University