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New treatment option for Chronic Lymphocytic Leukemia
Official title Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05336812
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196.
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 phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells.
- 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
- Men and women \>= 18 years of age
- Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines
- Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of...
- Patients must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria:
- Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic...
You likely can't join if
- Patients with high-risk disease as defined by:
- Presence of deletion 17p13 on cytogenetic analysis by fluorescent in situ hybridization (FISH)
- Presence of TP53 mutation on next generation sequencing
- Presence of complex karyotype on cytogenetic evaluation
- Defined as \>= 3 karyotypic abnormalities
- Treatment with a moderate or strong CYP3A inhibitor or inducer within 7 days prior to first dose of acalabrutinib or venetoclax or need for treatment...
See the full eligibility criteria
Who can join
- Men and women \>= 18 years of age
- Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop (iw)CLL guidelines
- Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or...
- Patients must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria:
- Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
- Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
- Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy
- Progressive lymphocytosis with a lymphocyte doubling time \ = 50% over a 2 month period
- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
- Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, spine)
- Constitutional symptoms, which include any of the following:
- Unintentional weight loss of 10% or more within 6 months
- Significant fatigue
- Fevers \> 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection
- Night sweats \>= 1 month without evidence of infection
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL/SLL and/or disease-related immune...
- Absolute neutrophil count (ANC) \>= 1000/mm\^3
- Platelets \>= 30,000/mm\^3
- Hemoglobin \>= 7 g/dL
- Total bilirubin =\< 2.0 x upper limit of normal (ULN) (excepting Gilbert's syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- Creatinine clearance \>= 30 mL/min/1.73m\^2
- Using 24-hour creatinine clearance or modified Cockcroft-Gault equation
- Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for at least 2 days after last acalabrutinib dose, 30 days after last venetoclax...
- Willing and able to participate in all required evaluations and procedures in this study protocol
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
What rules you out
- Patients with high-risk disease as defined by:
- Presence of deletion 17p13 on cytogenetic analysis by fluorescent in situ hybridization (FISH)
- Presence of TP53 mutation on next generation sequencing
- Presence of complex karyotype on cytogenetic evaluation
- Defined as \>= 3 karyotypic abnormalities
- Treatment with a moderate or strong CYP3A inhibitor or inducer within 7 days prior to first dose of acalabrutinib or venetoclax or need for treatment with a strong CYP3A inhibitor or inducer during the period or the...
- Known active involvement of the central nervous system by lymphoma or leukemia
- Subject with other malignancies that are associated with a life expectancy of \< 2 years or that would confound assessment of toxicity in this study
- 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...
- Is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication
- Known history of infection with human immunodeficiency virus (HIV)
- people with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection. people on prophylactic antibiotics or antivirals are...
- Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) unrelated to underlying CLL
- Patients with uncontrolled autoimmune disease requiring \> 20 mg of daily prednisone or equivalent
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
- Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
- Major surgical procedure within 28 days of 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 the...
- Hepatitis B or C serologic status:
- 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 polymerase chain reaction (PCR) and must be willing to undergo...
- people who are hepatitis C antibody positive will need to have a negative PCR result to be eligible. Those who are hepatitis C PCR positive will be excluded
- Breastfeeding or pregnant
- Vaccination with live vaccines 28 days prior to registration for study screening
- Concurrent participation in another therapeutic clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, 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 Columbus, 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.