NCT06958705招募中2 期
Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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 ≤
- •10. Ability to provide informed consent and adhere to the required follow-up.
排除标准
- •1. Richter transformation.
- •2. Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- •3. Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the study drug.
- •4. Grade 3 or 4 hemorrhage within the past 3 weeks.
- •5. Uncontrolled active infections (viral, bacterial, and fungal).
- •6. Females who are pregnant or lactating.
- •7. Known HIV positive.
- •8. Active hepatitis B infection (defined as the presence of detectable HBV DNA or HBe antigen). Patients who are HBsAg positive or HBcAb positive are eligible, provided HBV DNA is negative. These patients must have monthly monitoring of HBV DNA for the duration of the study.
- •9. Active hepatitis C, defined by the detection of hepatitis C RNA in plasma by PCR.
- •10. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy > 20 mg prednisone daily or equivalent, within 7 days of starting venetoclax.
- •11. Received other therapeutic agents for CLL/SLL during BTK inhibitor treatment prior to enrollment.
- •12. Concurrent use of warfarin or equivalent vitamin K inhibitor or other oral anticoagulant treatment.
- •13. Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax.
- •14. Consuming grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting venetoclax.
- •15. Prior treatment with venetoclax or other Bcl-2 inhibitor.
- •16. Malabsorption syndrome or other condition that precludes enteral route of administration.
研究组 & 干预措施
CLL/SLL patients on ibrutinib monotherapy for ≥ 6 months
Experimental
干预措施: Venetoclax combined with Ibrutinib (Drug)
CLL/SLL patients on zanubrutinib monotherapy for ≥ 6 months
Experimental
干预措施: Venetoclax combined with Zanubrutinib (Drug)
CLL/SLL patients on acalabrutinib monotherapy for ≥ 6 months
Experimental
干预措施: Venetoclax combined with Acalabrutinib (Drug)
CLL/SLL patients on orelabrutinib monotherapy for ≥ 6 months
Experimental
干预措施: Venetoclax combined with Orelabrutinib (Drug)
结局指标
主要结局
Rate of BM-uMRD after completion of combination therapy (Day 1 of Cycle 16)
时间窗: On Day 1 of Cycle 16 (each cycle is 28 days)
Rate of BM-uMRD is defined by negative MRD in the bone marrow by flow cytometry at a sensitivity of 10\^-4. The Clopper Pearson method is used to estimate the 95% two-sided confidence interval (CI) of the rate of BM-uMRD.
次要结局
- Rate of undetected peripheral blood MRD by flow cytometry(On screening, Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 16, Day 1 of Cycle 20, Day 1 of Cycle 24, Day 1 of Cycle 28 and Day 1 of Cycle 34 (each cycle is 28 days))
- Rate of complete response (CR)(On Day 1 of Cycle 7, Day 1 of Cycle 16, Day 1 of Cycle 22, and Day 1 of Cycle 28 (each cycle is 28 days))
- Progression-free survival (PFS)(From the first dose of venetoclax until the date of progression or date of death from any cause, whichever came first, assessed up to 112 months)
- Overall survival (OS)(From the first dose of venetoclax until the date of death from any cause, assessed up to 112 months)
- Time to next treatment (TTNT)(From the first dose of venetoclax to the next CLL-directed therapies due to progression, assessed up to 112 months)
- Adverse Events(From screening to 30 days after the end of cycle 12 (each cycle is 28 days))
研究者
研究点 (1)
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