Actively Recruiting
Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Led by PETHEMA Foundation · Updated on 2024-10-24
106
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase II randomized open label study is to compare the rate of complete remission (CR) with undetectable minimal residual disease (uMRD) obtained with zanubrutinib in combination with obinutuzumab with two different schedules of administration of obinutuzumab (starting obinutuzumab at cycle 2 or 12 months) in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). There is scarce information about which is the most appropriate schedule of combining the BTKi and the anti-CD20 monoclonal antibody, and whether treatment can be safely stopped in those patients attaining deep responses (CR with uMRD) remains to be determined. Response will be assessed after 20 cycles of treatment for the primary objective of the study. Patients attaining uMRD will stop treatment with zanubrutinib, whereas the rest of patients will continue on treatment with zanubrutinib until progression, unacceptable toxicity, or trial completion, whichever comes first.
CONDITIONS
Official Title
Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) diagnosed by IWCLL criteria.
- Ability to understand and voluntarily sign informed consent.
- Documented diagnosis meeting at least one of the following: progressive marrow failure (anemia/thrombocytopenia), large or symptomatic spleen, large or symptomatic lymph nodes, rapid lymphocyte increase, disease-related symptoms (weight loss, fatigue, fever, night sweats), autoimmune complications, or symptomatic extranodal involvement.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Women of childbearing potential must use highly effective contraception during and after the study for specified durations.
- Men must be vasectomized or agree to use barrier contraception and highly effective methods during and after the study.
- Female subjects of childbearing potential must have a negative pregnancy test at screening.
You will not qualify if you...
- Prior treatment for CLL.
- Known active HIV, Hepatitis B, or Hepatitis C infection (with some exceptions for resolved Hepatitis B).
- Estimated kidney function below 30 mL/min/1.73m2.
- Low neutrophil count (ANC less than 1.0 X 109/L).
- Low platelet count (less than 75 X 109/L, or less than 30 X 109/L if bone marrow involvement).
- Elevated liver enzymes or bilirubin above specified limits.
- Abnormal blood clotting tests.
- Active bleeding or bleeding disorders.
- Inability to swallow capsules or significant gastrointestinal issues affecting drug absorption.
- Active serious cardiovascular disease or recent heart attack.
- Need for warfarin or equivalent anticoagulants near study start.
- Unresolved systemic infection.
- Pregnant or breastfeeding women.
- Participation in another clinical trial or investigational therapy within 28 days.
- Central nervous system involvement by disease.
- Recent history of other cancers unless disease-free for at least 3 years, with some exceptions.
- Autoimmune hemolytic anemia or thrombocytopenia.
- Major surgery within 28 days.
- Recent stroke or brain bleeding within 6 months.
- Need for strong CYP3A4/5 inhibitors.
- Known allergy or severe reaction to study drugs.
- Any life-threatening illness or condition that could risk safety or study results as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
H. Vall d'Hebron
Barcelona, Spain
Actively Recruiting
Research Team
P
Pau Abrisqueta
CONTACT
F
Francesc Bosch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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