Is NCT06839053 recruiting in Seattle, WA?

Yes, NCT06839053 is currently recruiting participants at its Seattle, WA location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the 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.

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.

Chronic Lymphocytic Leukemia Clinical Trial in Seattle, WA

About This Chronic Lymphocytic Leukemia Study in Seattle

This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

Inclusion Criteria

Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or analyses

Age 18 years or older

Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:

CLL/SLL COHORT: CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria:

Meeting the following sets of prior treatment criteria:

For the R/R cohort, disease that relapsed after, or was refractory to, at least 1 prior therapy

For the treatment-naïve cohort, patients should have no prior treatment for CLL/SLL (other than 1 aborted regimen \< 2 weeks in duration and \> 4 weeks before enrollment)

Requiring treatment per International Workshop on CLL (iwCLL) criteria

MCL COHORT: WHO-defined MCL

R/R MCL is defined as a disease that relapsed after, or was refractory to, at least 1 prior systemic therapy

Measurable disease, defined as:

CLL/SLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)/magnetic resonance imaging (MRI) or clonal lymphocytes \>= 5 x 109/L present on peripheral blood flow cytometry

MCL, or SLL: at least 1 lymph node \> 1.5 cm in the longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT/MRI

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L =\< 7 days before the first dose of the study drug with or without growth factor support. There is an exception for patients with bone marrow involvement, in which case ANC must be \>= 0.75 x 10\^9/L before the first dose of the study drug

Platelets \> 75,000 x 10\^9/L (\> 75,000 cells/mm\^3) =\< 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions. Patients with bone marrow involvement will be allowed to have a platelet count \> 50,000 x 10\^9/L (\> 50,000 cells/mm\^3) =\< 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions

Hemoglobin \> 75 g/L =\< 7 days before the first dose of the study drug (with or without transfusion)

Creatinine clearance or glomerular filtration rate (GFR) \>= 50 mL/min as estimated by one of the following:

Cockcroft-Gault equation

Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

24-hour urine collection

Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase =\< 2 x upper limit of normal (ULN)

Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase =\< 2 x ULN

Total bilirubin level =\< 1.5 x ULN (unless documented Gilbert's syndrome). For patients with documented Gilbert's syndrome, total bilirubin may exceed this value, but direct bilirubin must be =\< 1.0 x ULN

Serum amylase =\< 1.5 x ULN

Serum lipase =\< 1.5 x ULN

Women of childbearing potential (WOCBP) must have a negative serum pregnancy test =\< 7 days before the first dose of the study drug. In addition, they must use a highly effective method of birth control initiated before the first dose of the study drug, for the duration of the study treatment period, and for \>= 180 days after the last dose of the study drug

NOTE: WOCBP is a woman who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)

NOTE: Highly effective contraceptive methods include the following:

Combined (estrogen and progestogen-containing) hormonal contraception associated with the inhibition of ovulation. Combined hormonal contraception may be oral, intravaginal, or transdermal

Progestogen-only hormonal contraception associated with the inhibition of ovulation. Progesterone-only hormonal contraception may be oral, injectable, or implantable

An intrauterine device

Intrauterine hormone-releasing system

Bilateral tubal

Vasectomized partner

Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day before the first dose of study treatment, for the duration of the study, and for \>= 180 days after the last dose of study drug. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception

Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above

For patients using hormonal contraceptives such as birth control pills or devices, a second barrier method of contraception (e.g., condoms) must be used

Nonsterile men must use a highly effective method of birth control along with barrier contraception for the duration of the study treatment period and for ≥ 180 days after the last dose of the study drug. During this same period, they must not donate sperm. Sterile men must use barrier contraception

Life expectancy of \> 6 months

Able to comply with the requirements of the study

Exclusion Criteria

Exposure to a Bcl-2 inhibitor within the last 12 months or a history of disease progression while taking a Bcl-2 inhibitor

Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, melanoma, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score =\< 6 prostate cancer

Underlying medical conditions that may render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results

Known current central nervous system involvement by lymphoma/leukemia

Known plasma cell neoplasm other than a monoclonal gammopathy of undetermined significance (MGUS), prolymphocytic leukemia, or history of or currently suspected Richter's syndrome

Prior autologous stem cell transplant unless \>= 3 months after transplant; or prior chimeric antigen receptor T-cell (CAR-T) therapy unless \>= 3 months after cell infusion

Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for the treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent

History of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention

Use of the following substances prior to the first dose of the study drug:

=\< 28 days before the first dose of the study drug:

Any biologic and/or immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, e.g., rituximab, and/or cancer vaccine therapy). If biological and/or immunologic-based therapy(ies) are used for non-oncological indications, enrollment will be at the discretion of the principal investigator (PI)

=\< 14 days before the first dose of the study drug:

Systemic chemotherapy or radiation therapy

=\< 7 days before the first dose of the study drug:

Corticosteroid given with antineoplastic intent

=\< 3 days (or 5 half-lives; whichever is shorter) before the first dose of the study drug:

Bruton's tyrosine kinase inhibitor (BTKi) or other small molecule inhibitor is given with antineoplastic intent

Active fungal, bacterial, and/or viral infection requiring systemic therapy

Note: oral antibiotics for minor bacterial infections are allowed

Major surgery =\< 4 weeks before the first dose of study treatment

Toxicity from prior anticancer therapy that has not recovered to grade =\< 1 (except for alopecia, ANC, and platelet count; for ANC and platelet count)

Clinically significant cardiovascular disease including the following:

Myocardial infarction =\< 6 months before screening

Unstable angina =\< 3 months before screening

New York Heart Association class III or IV congestive heart failure

History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)

Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula

History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place

Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements, at screening, showing systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg

Known infection with human immunodeficiency virus (HIV) or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

Presence of viral hepatitis B surface antigen (HBsAg) or viral hepatitis B core antibody (HBcAb)

Note: Patients with the presence of HBcAb, but absence of HBsAg, are eligible if HBV deoxyribonucleic acid (DNA) is undetectable and if they are willing to take HBV reactivation prophylaxis and undergo monitoring for HBV reactivation

Presence of HCV antibody

Note: Patients with the presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable and if they are willing to undergo monitoring for HCV reactivation

Pregnant or lactating women

Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedure, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction

Inability to comply with study procedures

Receiving any treatment with a strong or moderate CYP3A4 inhibitor =\< 14 days (or 5 half-lives, whichever is longer) before the first dose of sonrotoclax

Unwillingness to stop consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before the first dose of sonrotoclax or during the study

Receiving any treatment with a strong CYP3A4 inducer =\< 14 days (or 5 half-lives, whichever is longer) before first dose of sonrotoclax

History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis and acute lung diseases

Autoimmune anemia and/or thrombocytopenia that is poorly controlled by corticosteroids or other standard therapy

Ongoing, drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension

Receiving drugs known to prolong the QT/corrected QT (QTc) interval

Vaccination with a live vaccine =\< 35 days before the first dose of the study drug

Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed

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 (NCT06839053) 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.

Chronic Lymphocytic Leukemia Treatment Options in Seattle, WA

If you're searching for chronic lymphocytic leukemia treatment options in Seattle, WA, this clinical trial (NCT06839053) 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 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 Seattle, WA

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