Is NCT06757647 recruiting in Columbus, OH?

Yes, NCT06757647 is currently recruiting participants at its Columbus, OH location. This chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Clinical Trial in Columbus, OH

Q: How do I join the chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Study in Columbus

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.

Sponsor: Seema Bhat

Who Can Participate

Inclusion Criteria

Men and women \>= 18 years of age

Diagnosis of CLL/SLL meeting criteria as defined by International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2018 criteria

CLL patients cardiac intolerant to current treatment with ibrutinib as defined by AF or other cardiac arrhythmias. Other ibrutinib-related intolerances will be excluded

Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

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)

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)

Total bilirubin =\< 1.5 x upper limit of normal (ULN) (excepting Gilbert's syndrome) (at screening)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (at screening)

Creatinine clearance \>= 30 mL/min/1.73m\^2 (at screening)

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 2 days after the last dose of acalabrutinib

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

Exclusion Criteria

Prior exposure to acalabrutinib for primary cohort and prior exposure to BTK inhibitor for pilot cohort

Presence of C481S mutation or PCLG2 mutation

Disease progression on ibrutinib

History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:

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

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

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

Prior allogeneic stem cell transplantation

Prior cardiac transplantation

Systemic or non-cancer targeted anti-inflammatory medications (i.e., steroids)

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

Has difficulty with or is unable to swallow oral medication or has significant. gastrointestinal disease that would limit absorption of oral medication

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 \[PCR\])

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 AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)

Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening

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

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

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

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 first dose of study drug

Received a live virus vaccination within 28 days of first dose of study drug

History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)

Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug

Hepatitis B or C serologic status:

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

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

Breastfeeding or pregnant

Concurrent participation in another therapeutic clinical trial

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT06757647) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treatment Options in Columbus, OH

If you're searching for chronic lymphocytic leukemia/small lymphocytic lymphoma treatment options in Columbus, OH, this clinical trial (NCT06757647) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic lymphocytic leukemia/small lymphocytic lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Clinical Trial in Columbus, OH

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