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New treatment option for Recurrent Chronic Lymphocytic Leukemia
Official title Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
ClinicalTrials.gov ID: NCT04941716
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent 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 is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
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 or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria.
- Active disease per IWCLL 2018 criteria that require treatment. At least one of the following:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- Massive (\> 6 cm below left costal margin), progressive, or symptomatic splenomegaly
You likely can't join if
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation (biopsy based on clinical suspicion may be needed to...
- Prior disease progression while on a BTK inhibitor
- Prior disease progression while on venetoclax
- Prior intolerance to acalabrutinib or venetoclax
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ...
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction...
See the full eligibility criteria
Who can join
- Men and women \>= 18 years of age.
- Diagnosis of CLL or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria.
- Active disease per IWCLL 2018 criteria that require treatment. At least one of the following:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- Massive (\> 6 cm below left costal margin), progressive, or symptomatic splenomegaly
- Massive nodes (\> 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy
- Progressive lymphocytosis with an increase of \> 50% over a 2-month period or lymphocyte-doubling time of \< 6 months. Lymphocyte-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte...
- Constitutional symptoms, defined as any 1 or more of the following disease-related symptoms or signs
- Unintentional weight loss of \> 10% within the previous 6 months
- Significant fatigue
- Fevers \> 100.5 degrees Fahrenheit (F) or 38 degrees Celsius (C) for 2 weeks without other evidence of infection
- Night sweats for \> 1 month without evidence of infection
- Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current National Comprehensive Cancer...
- Absolute neutrophil count (ANC) \>= 750 cells/microliter (0.75 x 10\^9/L); ANC \>= 500 cells/microliter (0.50 x 10\^9/L) in people with documented bone marrow involvement of CLL (independent of growth factor or...
- Hemoglobin \>= 10 g/dL (independent of growth factor or transfusion support within 1 week of screening).
- Platelet count \>= 50,000 cells/microliter (50 x 10\^9/L); platelet count \>= 25,000 cells/microliter (25 x 10\^9/L) in people with documented bone marrow involvement of CLL (independent of growth factor or transfusion...
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
- Total bilirubin =\< 2 x ULN, unless directly attributable to Gilbert's syndrome
- Estimated creatinine clearance of \>= 50 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 30 days after the last dose of acalabrutinib or venetoclax, whichever occurs...
- Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules or tablets without difficulty
- Ability to understand the purpose and the risks of the study and provide signed and dated informed consent and authorization to use protected health information
What rules you out
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation (biopsy based on clinical suspicion may be needed to rule out transformation)
- Prior disease progression while on a BTK inhibitor
- Prior disease progression while on venetoclax
- Prior intolerance to acalabrutinib or venetoclax
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, low-grade prostate carcinoma (Gleason grade =\ = 2...
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac diseases as...
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or...
- Known history of drug-specific hypersensitivity or anaphylaxis to acalabrutinib or venetoclax
- Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease), or requires/is receiving anticoagulation with warfarin or equivalent vitamin K antagonists
- Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastic time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducers. The use of strong or moderate CYP3A inhibitors or inducers within 7 days of the first dose of study drug is prohibited.
- For patients receiving capsule formulation of acalabrutinib only: Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) at the time of...
- 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 7 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 first...
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis...
- Breastfeeding or pregnant
- Concurrent participation in another therapeutic clinical trial
- Known history of infection with human immunodeficiency virus (HIV) or any active significant infection (e.g,. bacterial, viral, or fungal)
- History of or ongoing confirmed central nervous system (CNS) CLL
- History of confirmed progressive multifocal leukoencephalopathy (PML)
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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 Seattle, Washington, 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.