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A Phase III Open-Label Trial of Acalabrutinib Plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
EU CTIS ID: 2023-505866-27-00
What this study is testing
To assess whether MRD-driven finite AV treatment is NI to MRD-driven finite VO treatment with respect to PFS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥ 18 years at the time of signing the consent form
- Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018) including a detectable clonal B-cell population at baseline for purposes of measuring for MRD
- Adequate BM function independent of growth factor or platelet transfusion support within 2 weeks of screening initiation as follows: (a) Absolute neutrophil count ≥ 1.0 × 10^9/L; absolute neutrophil count ≥ 500 cells/μL (≥ 0.50 × 10^9/L) with documented BM involvement of CLL/SLL (b) Platelet counts ≥ 30 × 10^9/L; platelet count ≥ 10 × 10^9/L in participants with documented BM involvement of CLL/SLL
- Estimated CrCL of ≥ 30 mL/min, calculated by Cockcroft-Gault (using actual body weight), or serum creatinine < 2 × ULN: Males: CrCL (mL/min) = Weight (kg) × (140 - Age) / 72 × serum creatinine (mg/dL) Females: CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85 / 72 × serum creatinine (mg/dL)
- Meet the following laboratory parameters (ULN is based on institutional standards): (a) Serum AST and ALT ≤ 3 × ULN (Higher thresholds may be allowed if hepatic dysfunction is attributable to CLL/SLL and after discussion with the Sponsor Hematology Safety Knowledge Group). (b) Total bilirubin ≤ 1.5 × ULN, unless directly attributable to Gilbert's syndrome
- An ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
You likely can't join if
- As judged by the investigator, any evidence of past or current diseases that, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize their safety or compliance with the protocol or would put the study at risk
- Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
- Concurrent participation in another therapeutic clinical trial. Use of investigational agents that interfere with the study intervention(s) within 30 days or 5 half-lives (whichever is longer) prior to registration for study screening
- Prothrombin time/INR or activated partial thromboplastin time, in the absence of lupus anticoagulant or attributed to anticoagulant (eg, direct oral anticoagulant) > 2 × ULN
- Currently pregnant (confirmed with positive pregnancy test) or breast feeding
- WOCBP unless the following criteria are met: a negative pregnancy test at least 30 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed every cycle and as clinically indicated.
See the full eligibility criteria
Who can join
- Participant must be ≥ 18 years at the time of signing the consent form
- Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018) including a detectable clonal B-cell population at baseline for purposes of measuring for MRD
- Adequate BM function independent of growth factor or platelet transfusion support within 2 weeks of screening initiation as follows: (a) Absolute neutrophil count ≥ 1.0 × 10^9/L; absolute neutrophil count ≥ 500 cells/μL (≥ 0.50 × 10^9/L) with documented BM involvement of CLL/SLL (b) Platelet counts ≥ 30 × 10^9/L; platelet count ≥ 10 × 10^9/L in participants with documented BM involvement of CLL/SLL
- Estimated CrCL of ≥ 30 mL/min, calculated by Cockcroft-Gault (using actual body weight), or serum creatinine < 2 × ULN: Males: CrCL (mL/min) = Weight (kg) × (140 - Age) / 72 × serum creatinine (mg/dL) Females: CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85 / 72 × serum creatinine (mg/dL)
- Meet the following laboratory parameters (ULN is based on institutional standards): (a) Serum AST and ALT ≤ 3 × ULN (Higher thresholds may be allowed if hepatic dysfunction is attributable to CLL/SLL and after discussion with the Sponsor Hematology Safety Knowledge Group). (b) Total bilirubin ≤ 1.5 × ULN, unless directly attributable to Gilbert's syndrome
- An ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
What rules you out
- As judged by the investigator, any evidence of past or current diseases that, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize their safety or compliance with the protocol or would put the study at risk
- Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
- Concurrent participation in another therapeutic clinical trial. Use of investigational agents that interfere with the study intervention(s) within 30 days or 5 half-lives (whichever is longer) prior to registration for study screening
- Prothrombin time/INR or activated partial thromboplastin time, in the absence of lupus anticoagulant or attributed to anticoagulant (eg, direct oral anticoagulant) > 2 × ULN
- Currently pregnant (confirmed with positive pregnancy test) or breast feeding
- WOCBP unless the following criteria are met: a negative pregnancy test at least 30 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed every cycle and as clinically indicated.
- Clinically significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction, within 6 months of screening or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease)
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study intervention
- Child-Pugh B/C liver cirrhosis
- History of prior or current malignancy (including but not limited to known central nervous system involvement such as by CLL/SLL, leptomeningeal disease, or spinal cord compression, known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome) that could affect compliance with the protocol or interpretation of results. Possible examples where compliance or data interpretation may not be affected could include the following, per physician discretion. (a) Curatively treated BCC or SCC of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study. (b) Other cancers that have been curatively treated from which the participant is disease-free for ≥ 3 years without further treatment
- Any prior CLL/SLL-specific therapies, except prior rituximab if used for autoimmune cytopenias and not as anti-CLL/SLL treatment
- Corticosteroid use > 20 mg within 1 week before the first dose of study intervention, except as indicated for other medical conditions, such as autoimmune cytopenias, inhaled steroid for asthma, topical steroid use, or as premedication for administration of study intervention or contrast
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. 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 EU CTIS; the study team decides eligibility.