RECRUITING

Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.

Official Title

Prospective Phase 2 Study of the Effect of Acalabrutinib on Myocardium on Ibrutinib Exposed Patients With CLL

Quick Facts

Study Start:2025-05-27
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06757647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women \>= 18 years of age
  2. * Diagnosis of CLL/SLL meeting criteria as defined by International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2018 criteria
  3. * CLL patients cardiac intolerant to current treatment with ibrutinib as defined by AF or other cardiac arrhythmias. Other ibrutinib-related intolerances will be excluded
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
  5. * Absolute neutrophil count (ANC) \>= 1000/mm\^3 (Independent of growth factor support at screening unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia. If cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed. Patients with active uncontrolled autoimmune cytopenias are excluded)
  6. * Platelets \>= 30,000/mm\^3 (Independent of growth factor support at screening unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia. If cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed. Patients with active uncontrolled autoimmune cytopenias are excluded)
  7. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (excepting Gilbert's syndrome) (at screening)
  8. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (at screening)
  9. * Creatinine clearance \>= 30 mL/min/1.73m\^2 (at screening)
  10. * Using 24-hour creatinine clearance or modified Cockcroft-Gault equation
  11. * Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib
  12. * Willing and able to participate in all required evaluations and procedures in this study protocol
  13. * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
  1. * Prior exposure to acalabrutinib for primary cohort and prior exposure to BTK inhibitor for pilot cohort
  2. * Presence of C481S mutation or PCLG2 mutation
  3. * Disease progression on ibrutinib
  4. * History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
  5. * Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study
  6. * Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for \>= 3 years without further treatment
  7. * Clinically significant cardiovascular disease such as prior myocarditis, congestive heart failure, prior documented myocardial infarction (i.e., not self-reported), known infiltrative cardiomyopathy (ex. cardiac sarcoidosis, cardiac amyloidosis, etc.) or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study
  8. * Prior allogeneic stem cell transplantation
  9. * Prior cardiac transplantation
  10. * Systemic or non-cancer targeted anti-inflammatory medications (i.e., steroids)
  11. * Contradictions to MRI: non-compatible metal implant, weight \> 300 pounds (lbs.) (MRI scanner limit), severe claustrophobia, advanced or end-stage renal disease (ESRD) (contraindication to gadolinium), pregnancy, cognitive disabilities that may impair ability to comply with instructions or provide informed consent
  12. * Has difficulty with or is unable to swallow oral medication or has significant. gastrointestinal disease that would limit absorption of oral medication
  13. * Known history of infection with HIV or any active significant infection (e.g., bacterial, viral, or fungal) including subjects with positive cytomegalovirus \[CMV\] deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\])
  14. * Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
  15. * Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
  16. * Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
  17. * Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening
  18. * Requires treatment with a strong cytochrome P450 3A4 (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
  19. * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
  20. * Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN
  21. * Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study
  22. * History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
  23. * 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 first dose of study drug
  24. * Received a live virus vaccination within 28 days of first dose of study drug
  25. * History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
  26. * Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug
  27. * Hepatitis B or C serologic status:
  28. * Subjects 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 DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded
  29. * Subjects 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
  30. * Breastfeeding or pregnant
  31. * Concurrent participation in another therapeutic clinical trial

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Seema A Bhat, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Seema Bhat

  • Seema A Bhat, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma