Study of Nemtabrutinib Plus Venetoclax for CLL/SLL
This study is looking at a new combination of medicines, nemtabrutinib and venetoclax, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. It compares this new combination to a standard treatment of venetoclax plus rituximab. The main goal is to see if the nemtabrutinib and venetoclax combination is better at preventing the disease from getting worse. Researchers will also check for side effects and find the right dose of nemtabrutinib. You may be eligible if you have CLL/SLL that has relapsed or is refractory, and your doctors will need to check for specific genetic markers like TP53 mutations. The study plans to enroll about 735 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll about 735 participants. It compares two different drug combinations for CLL/SLL.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to approximately 28 months, and for discontinuing treatment due to adverse events for up to approximately 25 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
At a glance
Conditions
Where it's being run
65 sites across 50 statesStudy leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Part 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)Up to approximately 12 Weeks
DLT evaluation period is defined as 8 weeks after the first dose of the combination treatment of nemtabrutinib plus venetoclax Cycle 2 Day 1 in Part 1 + 4 weeks follow up. Each cycle is 4 weeks. DLTs are: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting \>7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib or venetoclax doses as a result of drug-related adverse events during the first 2 cycles; Grade 5 toxicity.
- Part 1: Number of Participants Experiencing Adverse Events (AEs)Up to approximately 28 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.
- Part 1: Number of Participants Discontinuing Study Treatment Due to AEsUp to approximately 25 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to AEs will be reported for Part 1.
- Part 2: PFS per the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Blinded Independent Central Review (BICR)Up to approximately 71 months
PFS is defined as the time from randomization to the first documented disease progression per iwCLL criteria 2018 as accessed by BICR, or death due to any cause, whichever occurs first. PFS will be presented.