Is NCT07218510 recruiting in Long Beach, CA?

Yes, NCT07218510 is currently recruiting participants at its Long Beach, CA location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the chronic lymphocytic leukemia clinical trial in Long Beach?

To join this clinical trial in Long Beach, 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 Long Beach 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 Long Beach, CA

About This Chronic Lymphocytic Leukemia Study in Long Beach

This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. 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. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Histologically confirmed or flow cytometry confirmed diagnosis of B-CLL/SLL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO)

No prior treatment for CLL/SLL, except steroids and/or rituximab to treat autoimmune complications

Evidence of CD20 positivity

Active disease meeting criteria for requiring treatment per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines

A minimum of any one of the following constitutional symptoms:

Unintentional weight loss \> 10% within the previous 6 months prior to screening

Extreme fatigue (unable to work or perform usual activities)

Fevers of greater than 100.5°F for ≥ 2 weeks without evidence of infection

Night sweats without evidence of infection

Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia

Massive (i.e., \> 6 cm below the left costal margin), progressive or symptomatic splenomegaly

Massive nodes or clusters (i.e., \> 10 cm in longest diameter) or progressive lymphadenopathy

Progressive lymphocytosis with an increase of \> 50% over a 2-month period, or an anticipated doubling time of less than 6 months

Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids

Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine)

Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible

Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3

NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement.

With bone marrow involvement: ANC ≥ 500/mm\^3

NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement.

Without bone marrow involvement: Platelets ≥ 50,000/mm\^3

NOTE: independent of transfusion support, with no active bleeding

With bone marrow involvement: Platelets ≥ 30,000/mm\^3

NOTE: independent of transfusion support, with no active bleeding

Direct bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease or compensated hemolysis directly attributable to CLL)

Aspartate aminotransferase (AST) ≤ 2.5 x ULN

Alanine aminotransferase (ALT) ≤ 2.5 x ULN

Estimated creatinine clearance of ≥ 40 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2009 formula

If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN

If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN

If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants

Women of childbearing potential (WOCBP): Negative serum pregnancy test

Agreement by females of childbearing potential to either abstain from heterosexual activity or use an effective method of birth control (failure rate of \< 1% per year) during the treatment period and through at least 30 days after the last dose of venetoclax, 18 months after the last dose of obinutuzumab, 12 months after the last dose of epcoritamab, and at least 4 months after the last dose of tocilizumab (if applicable). Women must refrain from donating eggs during this same period

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Examples of contraceptive methods with a failure rate of \< 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices

Agreement by males to either abstain from heterosexual activity or use a condom during the treatment period and through at least 30 days after the last dose of venetoclax, 4 months after the last dose of obinutuzumab, epcoritamab or tocilizumab (as applicable). Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy. Men must refrain from donating sperm during this same period

Exclusion Criteria

Chronic use of corticosteroids in excess of 20 mg/day prednisone or equivalent

Major surgery (under general anesthesia) within 30 days prior to cycle 1 day 1 (C1D1)

Uncontrolled coagulopathy or bleeding disorder. Direct oral anticoagulants are allowed

Exposure to vaccination with live vaccine within 30 days prior to C1D1, or anticipated need for such vaccination during treatment

Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation)

Current evidence of central nervous system involvement by the CLL

History of confirmed progressive multifocal leukoencephalopathy (PML)

History of prior malignancy except:

Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study

Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease

Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease

Asymptomatic prostate cancer managed with "watch and wait" strategy

Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)

Uncontrolled active systemic infection

Known positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) and a positive test result for HCV ribonucleic acid (RNA). Participants with positive serology are eligible in case of negative HCV RNA test results

Known positive test result for chronic hepatitis B virus (HBV) infection (defined by hepatitis B virus surface antigen \[HBsAg\] positivity)

Participants with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody) may be included if HBV deoxyribonucleic acid (DNA) is undetectable, provided that they are willing to undergo ongoing DNA testing

Antiviral prophylaxis may be administered as per institutional guidelines

Participants who have protective titers of hepatitis B virus surface antibody (HBsAb) after vaccination or prior but cured hepatitis B may be included if HBV DNA is undetectable

Participants with HIV may be enrolled if they are on concurrent highly active antiretroviral therapy (HAART) therapy, have undetectable HIV RNA levels and no evidence of HIV-related comorbidities (infections or malignancies), and provided that they meet all other protocol-defined eligibility criteria

Females only: Pregnant or breastfeeding

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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 Long Beach?

Yes, this clinical trial (NCT07218510) has an active research site in Long Beach, CA 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 Long Beach, CA

If you're searching for chronic lymphocytic leukemia treatment options in Long Beach, CA, this clinical trial (NCT07218510) 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 Long Beach research site is actively enrolling participants for this 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 Long Beach, CA

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