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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

No Placebo-Only Group

Pivotal Trial

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.

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I have HIV but meet all the trial's eligibility criteria.

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I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~104 months

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

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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemtabrutinib

2023

Completed Phase 1

~100

0 / 3Eligibility criteria met