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Bruton's Tyrosine Kinase (BTK) Inhibitor

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
Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~104 months
Awards & highlights

Summary

This trial is comparing the effectiveness of nemtabrutinib to ibrutinib or acalabrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Who is the study for?
This trial is for adults with a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment and have not been treated before. They should be able to perform daily activities with ease to moderate difficulty (ECOG 0-2), swallow pills, and if they have hepatitis B or C, it must be under control. People with HIV can join if they meet all other criteria.
What is being tested?
The study compares Nemtabrutinib against either Ibrutinib or Acalabrutinib in treating CLL/SLL patients without prior therapy. It aims to see if Nemtabrutinib works as well as the others in shrinking tumors and helps patients stay disease-free longer.
What are the potential side effects?
Potential side effects include diarrhea, headache, fatigue, muscle and bone pain, rash, fever, bruising or bleeding easily due to low blood platelets; some may experience heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with CLL/SLL and need treatment.
Select...
I have HIV but meet all the trial's eligibility criteria.
Select...
I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~104 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~104 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
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by 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 One or More Adverse Events (AEs)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NemtabrutinibExperimental Treatment1 Intervention
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Group II: Ibrutinib/AcalabrutinibActive Control2 Interventions
Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.

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Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,173,783 Total Patients Enrolled
96 Trials studying Lymphoma
7,528 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,580 Total Patients Enrolled
42 Trials studying Lymphoma
10,592 Patients Enrolled for Lymphoma
~800 spots leftby Sep 2032
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