Is NCT05336812 recruiting in Columbus, OH?

Yes, NCT05336812 is currently enrolling participants at its Columbus, OH location. This chronic lymphocytic leukemia clinical trial is accepting qualified participants.

How do I join the chronic lymphocytic leukemia 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.

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 Clinical Trial in Columbus, OH: Acalabrutinib

About This Chronic Lymphocytic Leukemia Study in Columbus

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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.

Sponsor: Ohio State University Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

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 corticosteroids for symptoms control

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 \< 6 months or an increase of \>= 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 thrombocytopenia, or anemia. If cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed. Patients with active uncontrolled autoimmune cytopenias are excluded

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 dose, and 6 months after last obinutuzumab dose

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

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 study. Patients who have a need for treatment with a moderate CYP3A inhibitor or inducer during acalabrutinib or venetoclax dose escalation will also be excluded

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 York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study

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)

Subjects with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection. Subjects on prophylactic antibiotics or antivirals are acceptable

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 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 deoxyribonucleic acid (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

Vaccination with live vaccines 28 days prior to registration for study screening

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 (NCT05336812) 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 Treatment Options in Columbus, OH

If you're searching for chronic lymphocytic leukemia treatment options in Columbus, OH, this clinical trial (NCT05336812) 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 phase 2 clinical trial. You'll receive care from experienced chronic lymphocytic leukemia 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 clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia Clinical Trial in Columbus, OH

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