A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator’s Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501697-19-01

Acronym

MK-1026-011

Enrollment

407

Registered

2024-06-12

Start date

2024-06-18

Completion date

Unknown

Last updated

2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Lymphocytic Lymphoma (SLL) / Untreated Chronic Lymphocytic Leukemia (CLL)

Brief summary

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

Detailed description

Overall Survival (OS), Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR, Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGIBRUTINIB

DRUGNemtabrutinib

DRUGACALABRUTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Overall Survival (OS), Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR, Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE	—

Countries

Belgium, Czechia, Denmark, Germany, Greece, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026