A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

May 14, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

735

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1414
        • Recruiting
        • Centro Medico Fleischer ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148544097
      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman-oncohematologic diseases ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148277000
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: +542234963224
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414200222
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +61870740000
    • Victoria
      • Melbourne, Victoria, Australia, 3021
        • Recruiting
        • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +61383959130
  • Belgium
      • Antwerp, Belgium, 2030
        • Recruiting
        • ZAS Cadix ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 3/339 76 38
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven-Hematology ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 16/338544
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Active, not recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital ( Site 1414)
        • Contact:
          • Study Coordinator
          • Phone Number: 506-870-2404
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 450-466-5000 x3226
      • Sherbrooke, Quebec, Canada, J1H 5H4
        • Recruiting
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: 819-346-1110 x12811
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070196
        • Recruiting
        • Biocenter ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +56412858421
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +56958646664
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7580206
        • Recruiting
        • Clínica Inmunocel ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: +56224376600
  • Colombia
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3133288646
  • France
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: +333 20 44 59 62
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63100
        • Recruiting
        • Centre Hospitalier Universitaire Estaing ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: +33473750065
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85925
        • Recruiting
        • CHD Vendee ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +33251446572
  • Germany
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54290
        • Recruiting
        • Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +496519472571
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 341 97 13131
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247771514
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center-Hemato-Oncology ( Site 2812)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-539101736
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-Hemato Oncology ( Site 2809)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35308401
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 2811)
        • Contact:
          • Study Coordinator
          • Phone Number: +97237772649
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)
        • Contact:
          • Study Coordinator
          • Phone Number: +390131206440
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226436119
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
        • Contact:
          • Study Coordinator
          • Phone Number: +390522295654
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Centro de Infusion Superare ( Site 3314)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 55 5264 6440
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A. de C.V: ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 55 7586 4856
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Recruiting
        • Centro de Investigacion Clinica Chapultepec ( Site 3309)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 443 147 8545
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Auxilio Mutuo Cancer Center ( Site 3900)
        • Contact:
          • Study Coordinator
          • Phone Number: 7877582000
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • Alberts Cellular Therapy. ( Site 4401)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 12 993 2555
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Groote Schuur Hospital ( Site 4400)
        • Contact:
          • Study Coordinator
          • Phone Number: +27727689024
      • Kuilsriver, Western Cape, South Africa, 7580
        • Recruiting
        • Haemalife ( Site 4407)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 21 900 6277
  • Spain
    • Barcelona
      • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607750
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
        • Contact:
          • Study Coordinator
          • Phone Number: 914521900
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
        • Contact:
          • Study Coordinator
          • Phone Number: 961973930
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Completed
        • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Mega Medipol-Hematology ( Site 4904)
        • Contact:
          • Study Coordinator
          • Phone Number: 0212 444 70 44
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090 216 606 52 00
    • Tekirdas
      • Tekirdağ, Tekirdas, Turkey (Türkiye), 59100
        • Recruiting
        • Namik Kemal University Medical Faculty-Hematology ( Site 4912)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090 282 250 50 50
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 4902)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325566128
  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG5 1PF
        • Recruiting
        • City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: +44115969116972549
    • London, City of
      • London-Camden, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
        • Contact:
          • Study Coordinator
          • Phone Number: +4420 3447 2528
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group ( Site 5405)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-872-8130
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • MemorialCare Health System - Long Beach Medical Center ( Site 5421)
        • Contact:
          • Study Coordinator
          • Phone Number: 562-933-7866
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West ( Site 5410)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-844-8318
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Recruiting
        • Oregon Health and Science University ( Site 5425)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-494-5058
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates, PS ( Site 5406)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-462-2273
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Completed
        • University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy
  • Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only
  • Relapsed or refractory to at least 1 prior available therapy
  • Have 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 a life expectancy of at least 3 months
  • 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
  • Participants with adequate organ function with specimens collected within 7 days before the start of study intervention
  • If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception
  • Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding

Exclusion Criteria:

  • Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
  • Has gastrointestinal (GI) dysfunction that may affect drug absorption
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL
  • Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening
  • Clinically significant cardiovascular disease
  • Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients
  • Has history of severe bleeding disorders (eg, hemophilia)
  • Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization
  • Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
  • 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.
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
  • Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemtabrutinib + Venetoclax
Participants will receive nemtrabrutinib oral tablets at specified doses daily starting at Cycle 1 Day 1 (C1D1) and venetoclax oral tablets at doses of 20 mg up to 400 mg daily starting at Cycle 2 Day 1 (C2D1) up to 2 years post C2D1 or until progressive disease (PD) or discontinuation. A cycle = 4 weeks.
Drug: Venetoclax
10, 50, and 100 mg tablets
Other Names:
  • ABT-199
  • GDC-0199
Drug: Nemtabrutinib
5, 20, 45, and 65 mg tablets
Other Names:
  • MK-1026
  • ARQ 531
Active Comparator: Venetoclax + Rituximab
Participants will receive venetoclax oral tablets at doses from 20 mg up to 400 mg daily starting at C1D1 on 4-week cycles up to 2 years and rituximab or biosimilar at 375 mg/m^2 up to 500 mg/m2 intravenous infusion once per 28-day cycle starting at C2D1, for 6 total cycles. Treatment will continue until progressive disease (PD) or discontinuation.
Drug: Venetoclax
10, 50, and 100 mg tablets
Other Names:
  • ABT-199
  • GDC-0199
Biological: Rituximab
100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time Frame: Up to approximately 12 Weeks
DLT evaluation period is defined as 8 weeks after the first dose of the combination treatment of nemtabrutinib plus venetoclax Cycle 2 Day 1 in Part 1 + 4 weeks follow up. Each cycle is 4 weeks. DLTs are: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting >7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib or venetoclax doses as a result of drug-related adverse events during the first 2 cycles; Grade 5 toxicity.
Up to approximately 12 Weeks
Part 1: Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 28 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.
Up to approximately 28 months
Part 1: Number of Participants Discontinuing Study Treatment Due to AEs
Time Frame: Up to approximately 25 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to AEs will be reported for Part 1.
Up to approximately 25 months
Part 2: PFS per the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 71 months
PFS is defined as the time from randomization to the first documented disease progression per iwCLL criteria 2018 as accessed by BICR, or death due to any cause, whichever occurs first. PFS will be presented.
Up to approximately 71 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: Overall Survival (OS)
Time Frame: Up to approximately 108 months
OS, defined as the time from randomization to death due to any cause. OS will be presented.
Up to approximately 108 months
Part 2: Undetectable Minimal Residual Disease (MRD) Rate in Bone Marrow as Assessed by Central Laboratory
Time Frame: Up to approximately 46 months
Undetectable MRD, defined as <1 leukemic cell per 10,000 cells (MRD <10-4) in bone marrow. The MRD rate will be presented.
Up to approximately 46 months
Part 2: Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR
Time Frame: Up to approximately 71 months
OR, defined as complete response/remission (CR), complete response with incomplete count recovery (CRi), nodular partial remission (nPR), or partial remission (PR). CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow. ORR will be presented.
Up to approximately 71 months
Part 2: Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR
Time Frame: Up to approximately 108 months
DOR, defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow. DOR will be presented.
Up to approximately 108 months
Part 2: Number of Participants Experiencing AEs
Time Frame: Up to approximately 28 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2.
Up to approximately 28 months
Part 2: Number of Participants Discontinuing Study Treatment Due to AEs
Time Frame: Up to approximately 25 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to AEs will be reported for Part 2.
Up to approximately 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

July 1, 2035

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-010
  • MK-1026-010 (Other Identifier: MSD)
  • BELLWAVE-010 (Other Identifier: MSD)
  • 2022-501560-17-00 (Registry Identifier: EU CT)
  • U1111-1281-1520 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia, Lymphocytic, Chronic, B-Cell

Clinical Trials on Venetoclax

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe