Clinical trial for Chronic Lymphocytic Leukemia
Official title Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL
ClinicalTrials.gov ID: NCT07321652
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational oral medicine being studied as a potential treatment for chronic lymphocytic leukemia. It is designed to block a protein called BTK that helps cancer cells grow and spread.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares two treatment options to see if the combination of sonrotoclax and zanubrutinib works better than zanubrutinib alone for patients who have not yet received therapy for chronic lymphocytic leukemia or small lymphocytic lymphoma.
- Who it's for
- Adults who have been newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma and have not yet started treatment.
- What's involved
- Participants will receive either zanubrutinib alone or zanubrutinib plus sonrotoclax, along with regular medical visits and tests to monitor their health and the cancer’s response.
- Time commitment
- The trial lasts several months, with scheduled clinic visits and blood tests throughout the treatment period.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of...
- ≥ 5 x10\^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)
- On morphologic review, the leukemic cells must be small mature lymphocytes
- Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20...
- Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic...
See the full eligibility criteria
- STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of the clone needed for MRD testing.
- ≥ 5 x10\^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)
- On morphologic review, the leukemic cells must be small mature lymphocytes
- Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5.
- Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \< 10 g/dL...
- Massive (\> 6 cm below the costal margin), progressive or symptomatic splenomegaly
- Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
- Unintentional weight loss of ≥ 10% within the previous 6 months
- Significant fatigue (ie. Eastern Cooperative Oncology Group [ECOG] performance status [PS] ≥ 2)
- Fevers \>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection
- Night sweats \> 1 month without evidence of infection
- STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
- STEP 0: Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment.
- STEP 0: Age ≥ 65 years
- STEP 0: ECOG performance status ≤ 2
- STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
- STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured.
- STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment
- STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart...
- STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage
- STEP 0: No patients with known active progressive central nervous system (CNS) disease
- STEP 0: No known medical condition causing an inability to swallow oral formulations of agents
- STEP 1: The adaptive report confirming a measurable and trackable B cell clone
- STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment.
- STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document
- STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
- STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
- STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4/5 inhibitor or inducer.
- STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mm3 unless due to marrow involvement
- STEP 1: Platelet count ≥ 30,000/mm3
- STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)
- STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x upper limit of normal (ULN) unless due to...
- STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL/min
- STEP 1: Urine protein to creatinine ratio \< 1 or urine protein ≤ 1+
- STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ
- STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anaheim, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Dublin, California, United States
- Fontana, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Ontario, California, United States
- Panorama City, California, United States
- Riverside, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
+ 194 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anaheim, California, United States; Baldwin Park, California, United States; Bellflower, California, United States; Dublin, California, United States; Fontana, California, United States and 208 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.