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New treatment option for Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Official title Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
ClinicalTrials.gov ID: NCT06958705
What this study is testing
What is Venetoclax combined with Ibrutinib?
Venetoclax combined with Ibrutinib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia (cll) / small lymphocytic lymphoma (sll).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 5\. Patients need to have a response of at least PR (CR/PR) to BTK inhibitor monotherapy.
You likely can't join if
- 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...
- 3\. Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 3 weeks prior to the first dose of the...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.