Recruiting NCT06136559

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Phase III Interventional Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nemtabrutinib, Ibrutinib, Acalabrutinib.
Who it may be relevant to: Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Canada +24
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.

Interventions

Drug Nemtabrutinib
Administered orally
Drug Ibrutinib
Administered orally
Drug Acalabrutinib
Administered orally

Primary outcome measures

Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR) [Time frame: Up to ~33 months]
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR [Time frame: Up to ~104 months]

Secondary outcome measures (4)

Overall Survival (OS) [Time frame: Up to ~104 months]
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR [Time frame: Up to ~104 months]
Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to ~104 months]
Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to ~104 months]

Eligibility criteria

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
Has at least 1 marker of disease burden.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
Has the ability to swallow and retain oral medication.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
Has gastrointestinal (GI) dysfunction that may affect drug absorption.
Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
Has clinically significant cardiovascular disease.
Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
Has history of severe bleeding disorder.
Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
Has received any systemic anticancer therapy for CLL/SLL.
Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 46 centers

USA Mitchell Cancer Institute ( Site 0014) — Mobile
Banner MD Anderson Cancer Center ( Site 0059) — Gilbert
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051) — Phoenix
Arizona Oncology Associates - NAHOA ( Site 8007) — Prescott
Alta Bates Summit Medical Center ( Site 0004) — Berkeley
Moores Cancer Center ( Site 0003) — La Jolla
Care Access - South Pasadena ( Site 0070) — Pasadena
Saint Joseph Hospital ( Site 0026) — Denver
… and 38 more centers

China · 30 centers

Anhui Provincial Cancer Hospital ( Site 2001) — Hefei
Peking University First Hospital ( Site 2022) — Beijing
Peking University Third Hospital-Hematology ( Site 2011) — Beijing
Chongqing University Cancer Hospital ( Site 2041) — Chongqing
Sun Yat-sen University Cancer Center ( Site 2028) — Guangzhou
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) — Guangzhou
Liuzhou People's Hospital ( Site 2029) — Liuzhou
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) — Nanning
… and 22 more centers

Japan · 14 centers