Is NCT04941716 recruiting in Seattle, WA?

Yes, NCT04941716 is currently recruiting participants at its Seattle, WA location. This recurrent chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Seattle 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.

Recurrent Chronic Lymphocytic Leukemia Clinical Trial in Seattle, WA

Q: How do I join the recurrent chronic lymphocytic leukemia clinical trial in Seattle?

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

About This Recurrent Chronic Lymphocytic Leukemia Study in Seattle

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. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

Inclusion Criteria

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 counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of \< 30 x 109/L lymphocyte-doubling time should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (e.g., infection) should be excluded.

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 Network (NCCN) guidelines, or of an investigational regimen on a clinical trial.

Absolute neutrophil count (ANC) \>= 750 cells/microliter (0.75 x 10\^9/L); ANC \>= 500 cells/microliter (0.50 x 10\^9/L) in subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening).

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 subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening).

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 later

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

Exclusion Criteria

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 =\< 6) or other cancer from which the subject has been disease free for \>= 2 years or which will not limit survival to \< 3 years

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 defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec at screening. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.

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 complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. Patients with history of such operations are eligible if in treating physician's opinion they have no absorption issues.

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 enrollment. 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 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 dose of study drug

Hepatitis B or C serologic status: subjects 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 B surface antigen (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. Those who are hepatitis C PCR positive will be excluded.

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)

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 Seattle?

Yes, this clinical trial (NCT04941716) has an active research site in Seattle, WA 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.

Recurrent Chronic Lymphocytic Leukemia Treatment Options in Seattle, WA

If you're searching for recurrent chronic lymphocytic leukemia treatment options in Seattle, WA, this clinical trial (NCT04941716) 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 Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent 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 recurrent chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Recurrent Chronic Lymphocytic Leukemia Clinical Trial in Seattle, WA

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