How to read clinical trials
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Understanding a clinical trial listing[Lorem ipsum dolor sit amet, consectetur adipiscing elit. In facilisis, nunc vel facilisis ullamcorper, urna quam dictum mi, quis dictum velit tortor nec dolor.
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The goal of this study is to evaluate nemtabrutinib compared with investigator’s choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
NATIONAL TRIAL REFERENCE NUMBER | NCT06136559 | |
Merck Protocol ID | MK-1026-011 | |
Conditions | Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | |
Age Range | 18+ | |
Sex | All | |
Trial Phase | 1 | |
Trial start and end dates | [12-13-2023] [09-30-2032] |
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
All patients who enroll in the trial will receive medication while on the study.
50% will receive nemtabrutinib
50% will receive either ibrutinib or acalabrutinib
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
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Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
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Understanding a clinical trial listingLorem ipsum dolor sit amet, consectetur adipiscing elit. In facilisis, nunc vel facilisis ullamcorper, urna quam dictum m
Taking part in a clinical trialBefore you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study s purpose, assessments, procedures, potential benefits
and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal
information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more
information about how your privacy will be maintained.
Yes, your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw
early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final
visit and return any unused study drugs.
No, you will receive the study drugs at no cost. You will also get all study related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may
contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run
studies to test whether an investigational study drug is safe and effective. These research studies may help doctors find new ways to help prevent,
detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well being of people who volunteer for research
studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the US, this group is called an IRB or
Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical
history and current medical status against the eligibility criteria. They will determine whether you are eligible to participate. You may also be asked
to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational study drug is a drug that hasn t yet been approved for use in the general public. In order to be approved, the investigational
study drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/
Interested in this research study? Submit your information to be contacted to see if you may qualify.
The information you provide will be kept confidential.
Get StartedPrint this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
To learn more, call 1-888-577-8839.