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Compares treatment options for Chronic Lymphocytic Leukemia
Official title Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
ClinicalTrials.gov ID: NCT07014917
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for chronic lymphocytic leukemia.
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 a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- 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 and older
You may be able to join if
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry...
- Men and Women ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day...
- people must have adequate organ and marrow function as defined below:
- ANC ≥1,000/mcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500/mcL unless WBC...
You likely can't join if
- Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable...
- Patients with active Richter's transformation.
- History of or ongoing confirmed central nervous system (CNS) lymphoma.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered...
- History of prior malignancy that could affect compliance with the protocol or interpretation of results in the opinion of the investigator, except...
See the full eligibility criteria
Who can join
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL/SLL...
- Men and Women ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- people must have adequate organ and marrow function as defined below:
- ANC ≥1,000/mcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500/mcL unless WBC is \> to 50 x 109/L. If WBC is \> to 50 x 109/L there will be no lower...
- Platelets ≥30,000/mcL unless thrombocytopenia is due to extensive underlying CLL bone marrow disease platelets threshold will be ≥ 10, 000/mcl. Use of steroids for disease control is allowed.
- Total bilirubin ≤1.5 x ULN unless directly attributable to Gilbert's syndrome
- AST and ALT ≤3 × ULN
- Creatinine clearance (Cockcroft) ≥30 mL/min/1.73 m2 CrCl by Cockcroft and Gault method: CrCl (mL/min) = (140 - age [years]) × weight (kg) × (F)a (72 × serum creatinine mg/dL a where F = 0.85 for females and F = 1 for...
- Female people who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.
- Male people who are sexually active must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study.
- Men must agree to refrain from sperm donation during the study.
- Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing tablets without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy...
What rules you out
- Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize...
- Patients with active Richter's transformation.
- History of or ongoing confirmed central nervous system (CNS) lymphoma.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before...
- History of prior malignancy that could affect compliance with the protocol or interpretation of results in the opinion of the investigator, except for the following:
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, breast or prostate at any time prior to study that are adequately treated. Patients with cancer not...
- Continuation of maintenance therapy in patients with adequately treated malignancy
- Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy and/or chemotherapy from which subject is disease-free for ≥3 years without further treatment
- 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...
- Patients with a condition that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment. For example, refractory nausea and vomiting, inability to swallow the formulated product, or...
- Received a live virus vaccination within 28 days of first dose of study drug.
- Uncontrolled HIV infection.
- History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).
- Any active uncontrolled significant infection (e.g., bacterial, viral or fungal), including people with positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR]).
- Serologic status reflecting active hepatitis B or C infection.
- Note: people who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA...
- people who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- Uncontrolled bleeding diathesis (e.g., hemophilia, von Willebrand disease).
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. a. Note: DOAC or LMWH are not exclusionary.
- Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or 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...
- Breastfeeding or pregnant.
- Concurrent participation in another therapeutic clinical trial.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.
- Requires treatment with P-glycoprotein (P-gp) inhibitor during venetoclax initiating and dose escalation phase. Note: After initiation of the study drug(s) once a stable dose is reached if P-gp inhibitors are required...
- Patients who are unable to receive Prevnar vaccination.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, 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 ClinicalTrials.gov; the study team decides eligibility.