Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

BELLWAVE-011 MK1026-011 A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

In plain English

AI plain-English summary

A new drug called nemtabrutinib is being tested against two standard treatments in a trial of 1,200 people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. This matters because current drugs for these blood cancers—ibrutinib and acalabrutinib—stop working for some patients over time. The trial asks whether nemtabrutinib can keep the cancer from progressing longer than existing options, and whether it works in patients whose disease might resist older drugs. Participants take their assigned pill daily or twice daily until their cancer worsens, with follow-up lasting up to nine years. If nemtabrutinib proves superior, it could become a new first-line treatment for these leukemias, delaying the need for chemotherapy or more aggressive therapies. That would mean more years of disease control for patients, with a once-daily pill regimen that may have fewer side effects than current alternatives. An independent safety board monitors the trial and can stop it early if the drug shows no benefit or unexpected risks.

View original technical description
Researchers are looking for new ways to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Current treatments for CLL and SLL can slow cancer growth and help people to live longer. However, these treatments stop working for some people with CLL or SLL, and better treatments are needed.This is a clinical trial to compare nemtabrutinib (trial treatment) to ibrutinib or acalabrutinib (standard treatments). The goal of the trial is to learn if the cancer responds to treatment with nemtabrutinib as well as or better than treatment with ibrutinib or acalabrutinib. Researchers also want to learn if people who take nemtabrutinib live longer without the cancer getting worse than those who take standard treatments.About 1,200 people, aged 18 years or older, with CLL or SLL that have not received prior treatment will be in this trial. People will be assigned by equal chance to take either of these treatments by mouth:• Trial treatment: nemtabrutinib once a day• Standard treatment: ibrutinib once a day OR acalabrutinib twice a dayEach person will take their assigned treatment until the cancer gets worse or they need to stop treatment. Each person could be in the trial for up to 9 years (possibly longer if they continue to benefit from treatment). During the trial, people will give blood, urine and possibly bone marrow samples. They will also have imaging tests, physical examinations and answer sets of questions about their health.People may or may not benefit from the treatment received during the trial. This trial has an external group of experts that will oversee the overall risk and benefit. If this group of experts decides that the trial treatment is not safe or does not show benefit, the trial can be stopped.

Researchers

Nicolas Martinez-Calle (Principal Investigator)

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A Randomized, Open-label Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
TRAVERSE MCL A Phase II, randomized, open label, study to evaluate the efficacy of acalabrutinib in combination with rituximab and venetoclax in patients with untreated mantle cell lymphoma - TRAVERSE (D822GC00001)
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma with Acalabrutinib
A Multicentre, Phase II, Randomised, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination with Venetoclax and Rituximab in Participants with Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)
A randomized phase II trial evaluating Ibrutinib plus CD20 Ab and Ibrutinib-Venetoclax plus CD20 Ab in patients with untreated mantle cell lymphoma

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