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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 94 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,846 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,919 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Nemtabrutinib be detrimental to patient health?

"Due to existing clinical evidence of efficacy and safety, our team at Power rated the security rating of Nemtabrutinib as a 3 out of 3."

Answered by AI

Are participants being recruited for the experiment at this time?

"This clinical trial is actively accepting candidates, as made evident on the information posted to clinicaltrials.gov. The experiment was first announced on March 16th 2023 and has seen its last update on September 26th of the same year."

Answered by AI

To what extent is the participation in this medical research experiment limited?

"To conduct the trial, 300 participants that meet all eligibility requirements are needed. The sponsor of this study is Merck Sharp & Dohme LLC and it will be conducted across two locations: Prince of Wales Hospital-Department of Medicine & Therapeutics (Haematology) in Shatin, Cesar and Sociedad De Oncologia Y Hematologia Del Cesar-Oncology in Valledupar, Antioquia."

Answered by AI

Is this trial being administered in multiple facilities located in Canada?

"This trial is currently being conducted at 67 different medical centres worldwide, such as Prince of Wales Hospital-Department of Medicine & Therapeutics (Haematology) in Shatin, Sociedad De Oncologia Y Hematologia Del Cesar-Oncology in Valledupar and Clini Salud in Envigado."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

2023. "A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624554.