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Alkylating agents

Nemtabrutinib for Chronic Lymphocytic Leukemia

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 94 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare a new drug (nemtabrutinib) to existing treatments for chronic lymphocytic leukemia/small lymphocytic lymphoma, to see if it can prevent progression of the disease.

Who is the study for?
This trial is for adults with untreated CLL/SLL who don't have TP53 mutations. They must need treatment, be able to take pills, and not have had major surgery recently or active hepatitis. People with other progressing cancers or severe bleeding disorders can't join.
What is being tested?
The study compares Nemtabrutinib's effectiveness and safety against standard chemoimmunotherapy (FCR/BR) in extending the time patients live without disease progression. Participants will either receive Nemtabrutinib or a combination of chemotherapy drugs plus Rituximab.
What are the potential side effects?
Possible side effects include nausea, fatigue, risk of infection due to low blood cell counts, allergic reactions to infusion drugs like Rituximab, and potential liver toxicity from chemotherapy agents.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 94 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 94 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)
Secondary study objectives
Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NemtabrutinibExperimental Treatment1 Intervention
Administered daily via oral tablet.
Group II: FCR or BRActive Control7 Interventions
Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemtabrutinib
2023
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,015 Previous Clinical Trials
5,186,033 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,889 Previous Clinical Trials
8,088,893 Total Patients Enrolled
~174 spots leftby May 2027
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