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Zanubrutinib + Rituximab for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing a new combination drug therapy for people with leukemia or lymphoma who haven't received treatment before. The therapy consists of two drugs: zanubrutinib and rituximab. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The study is being done to find out if zanubrutinib combined with rituximab can help control previously untreated chronic lymphocytic leukemia or small lymph
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently pregnant or breastfeeding.My blood tests show very low white blood cells or platelets.I can take care of myself and am up and about more than half of the day.I have had minor surgery or a biopsy within the last week, but bone marrow procedures are okay.I am not currently taking warfarin or similar drugs, or I switched to a NOAC/DOAC.I have been diagnosed with CLL/SLL and have not received any treatment.My kidneys work well enough, with a creatinine clearance over 30 mL/min.I am recommended for treatment based on the 2018 CLL guidelines.I haven't had any cancer except for some skin cancers or early-stage cervical or breast cancer in the last 3 years.I have not had any CLL treatments except possibly zanubrutinib plus rituximab in the last 21 days.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have active hepatitis B or C.I do not have an ongoing infection that isn't responding to treatment.I have not had bleeding or clotting problems in the last 3 months.I have not had a stroke or brain bleed in the last 6 months.I have uncontrolled autoimmune blood disorders that are worsening quickly.I do not have severe diseases or organ problems that could make treatment risky.I am using or willing to use effective birth control during and 30 days after the study.I do not have severe heart problems or recent serious heart events.I have previously been treated with drugs like zanubrutinib or ibrutinib.I have a serious wound or fracture that is not healing.
- Group 1: Treatment (zanubrutinib, rituximab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What medical conditions is Rituximab commonly utilized to manage?
"Rituximab is a known treatment for relapsed marginal zone lymphoma, in addition to various other malignancies including diffuse large b-cell lymphoma (DLBCL), B-cell lymphomas, and polyangiitis."
Is there still an opportunity to join this experiment?
"Affirmative. Information available on clinicaltrials.gov reveals that this research endeavour, which was initially launched on May 26th 2020, is presently recruiting participants from 1 location with a goal of finding 60 individuals to take part in the study."
How many participants are currently receiving treatment from this clinical research?
"Precisely. Clinicaltrials.gov's data shows that this investigation is currently accepting participants - the initial posting date was May 26th 2020 and it was recently modified on July 9th 2022. A total of 60 people will be admitted at a solitary medical facility for testing purposes."
To what extent are there adverse effects associated with Rituximab usage?
"Rituximab has been assigned a safety score of 2 since there is evidence to suggest its safety, but not yet any proof that it is effective."
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