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AzTrials

Chronic Lymphocytic LeukemiaPhase 3NCT05624554

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)

A Phase 3 study testing Nemtabrutinib, Fludarabine and Cyclophosphamide in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC at 97 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nemtabrutinib, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
97 sitesin 21 countries
Study dates
16 Mar 2023to 17 Mar 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy
  • Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status
  • The ability to swallow and retain oral medication

Who cannot join

  • Has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Has gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
  • Has history of severe bleeding disorders
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

97 sites in 21 countries.

97 sites in 21 countries

China23 sites

  • Peking University Third Hospital ( Site 1602)

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University-Hematology ( Site 1621)

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University-Hematology department ( Site 1616)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 1615)

    Changsha, Hunan, 410013

  • Chongqing University Cancer Hospital ( Site 1605)

    Chongqing, Chongqing Municipality, 400030

  • Chongqing University Three Gorges Hospital ( Site 1609)

    Chongqing, Chongqing Municipality, 404000

  • Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 1607)

    Guangzhou, Guangdong, 510515

  • Sun Yat-sen University Cancer Center ( Site 1608)

    Guangzhou, Guangdong, 510700

  • The Affiliated Hospital of Guizhou Medical University ( Site 1625)

    Guiyang, Guizhou, 550004

  • Hainan General Hospital ( Site 1603)

    Haikou, Hainan, 570311

  • The First Affiliated Hospital, Zhejiang University-Hematology ( Site 1611)

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Nanchang University ( Site 1614)

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital ( Site 1628)

    Nanchang, Jiangxi, 330029

  • Fudan University Shanghai Cancer Center ( Site 1606)

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital of Soochow University-hematology department ( Site 1612)

    Suzhou, Jiangsu, 215006

  • Shanxi Cancer Hospital ( Site 1629)

    Taiyuan, Shanxi, 030000

  • Institute of hematology&blood disease hospital ( Site 1600)

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 1604)

    Tianjin, Tianjin Municipality, 300060

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 1619)

    Wuhan, Hubei, 430000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1618)

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1617)

    Xi'an, Shaanxi, 710061

  • Shaanxi provincial people's hospital ( Site 1626)

    Xi'an, Shaanxi, 710068

  • Henan Cancer Hospital-hematology department ( Site 1613)

    Zhengzhou, Henan, 450008

Other trials in China

Brazil6 sites

  • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)

    Curitiba, Paraná, 81520-060

  • Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)

    Jaú, São Paulo, 17210-120

  • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1319)

    Rio de Janeiro, 20231-050

  • A. C. Camargo Cancer Center ( Site 1318)

    São Paulo, São Paulo, 01525-001

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)

    São Paulo, 01246-000

  • Hospital Paulistano-Americas Oncologia ( Site 1302)

    São Paulo, 01321-001

Other trials in Brazil

Chile6 sites

  • Biocenter ( Site 1507)

    Concepción, Biobio, 4070196

  • IC La Serena Research ( Site 1506)

    La Serena, Coquimbo Region, 1720430

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)

    Santiago, Region M. de Santiago, 7500653

  • FALP-UIDO ( Site 1500)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Inmunocel ( Site 1511)

    Santiago, Region M. de Santiago, 7580206

  • James Lind Centro de Investigacion del Cancer ( Site 1503)

    Temuco, Araucania, 4800827

Other trials in Chile

Poland6 sites

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)

    Gdansk, Pomeranian Voivodeship, 80-952

  • Pratia Onkologia Katowice ( Site 3705)

    Katowice, Silesian Voivodeship, 40-519

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 3711)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Uniwersytecki Szpital Kliniczny nr 1 w Lublinie ( Site 3710)

    Lublin, Lublin Voivodeship, 20-081

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 3704)

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 3701)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Ukraine6 sites

  • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 5106)

    Cherkassy, Cherkasy Oblast, 18009

  • Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 5113)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • Nonprofit Organization National Cancer Institute ( Site 5103)

    Kyiv, Kyivska Oblast, 03022

  • SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 5101)

    Kyiv, 03115

  • Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 -Hematology department #1 ( Site 5111)

    Kyiv, 04112

  • Institute of Blood Pathology and Transfusion Medicine of National Aсademy of Medical Sciences of Ukr ( Site 5105)

    Lviv, Lviv Oblast, 79057

Other trials in Ukraine

Bulgaria5 sites

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD ( Site 6404)

    Plovdiv, 4002

  • Medical Centre Pratia Clinic EOOD ( Site 6406)

    Plovdiv, 4003

  • Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403)

    Sofia, Sofia (stolitsa), 1797

  • UMHAT "Prof. Dr. Stoyan Kirkovich"AD-Clinical Hematology ( Site 6400)

    Stara Zagora, 6003

  • Multriprofile Hospital for Active Treatment "Hristo Botev" ( Site 6402)

    Vratsa, 3000

Other trials in Bulgaria

South Africa5 sites

  • Groote Schuur Hospital-Clinical Haematology ( Site 4400)

    Cape Town, Western Cape, 7925

  • Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)

    Centurion, Gauteng, 0181

  • Wits Clinical Research ( Site 4403)

    Johannesburg, Gauteng, 1864

  • Haemalife ( Site 4407)

    Kuilsriver, Western Cape, 7580

  • Constantiaberg Haematology ( Site 4408)

    Plumstead, Western Cape, 7800

Other trials in South Africa

Turkey (Türkiye)5 sites

  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)

    Ankara, 06100

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)

    Istanbul, 34722

  • Ege Universitesi Hastanesi ( Site 4902)

    Izmir, 35100

  • Mega Medipol-Hematology ( Site 4904)

    Stanbul, Istanbul, 34214

  • Namik Kemal University Medical Faculty-Hematology ( Site 4912)

    Suleymanpasa, Tekirdas, 59100

Other trials in Turkey (Türkiye)

United States4 sites

  • Clermont Oncology Center ( Site 5224)

    Clermont, Florida, 34711

  • Hattiesburg Clinic Hematology/Oncology ( Site 5216)

    Hattiesburg, Mississippi, 39401

  • Medical Oncology Associates, PS ( Site 5206)

    Spokane, Washington, 99208

  • Highlands Oncology Group ( Site 5205)

    Springdale, Arkansas, 72762

Other trials in United States

Colombia4 sites

  • Clini Salud ( Site 1700)

    Envigado, Antioquia, 055422

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)

    Medellín, Antioquia, 050030

  • Oncologos del Occidente ( Site 1706)

    Pereira, Risaralda Department, 660001

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1704)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Denmark4 sites

  • Aalborg Universitetshospital, Syd ( Site 1901)

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)

    Aarhus, Central Jutland, 8200

  • Odense Universitetshospital ( Site 1900)

    Odense C, Region Syddanmark, 5000

  • Vejle Sygehus ( Site 1903)

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Mexico4 sites

  • Centro de Infusion Superare ( Site 3314)

    Mexico City, Mexico City, 03100

  • Health Pharma Professional Research S.A. de C.V: ( Site 3301)

    Mexico City, Mexico City, 03100

  • Centro de Investigacion Clinica Chapultepec ( Site 3309)

    Morelia, Michoacán, 58260

  • Oaxaca Site Management Organization ( Site 3313)

    Oaxaca City, 68000

Other trials in Mexico

Guatemala3 sites

  • MEDI-K ( Site 2401)

    Guatemala City, 01009

  • CELAN,S.A ( Site 2403)

    Guatemala City, 01010

  • Oncomedica ( Site 2402)

    Guatemala City, 01010

Other trials in Guatemala

Hungary3 sites

  • Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 2608)

    Eger, Heves County, 3300

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Romania3 sites

  • Spitalul Clinic Colțea ( Site 4000)

    Bucharest, Bucharest, 030171

  • Spitalul Clinic Colțea ( Site 4001)

    Bucharest, Bucharest, 030171

  • Institutul Oncologic Cluj ( Site 4002)

    Cluj-Napoca, 400015

Other trials in Romania

Taiwan3 sites

  • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital ( Site 4701)

    Tainan, 704

  • National Taiwan University Hospital ( Site 4704)

    Taipei, 10002

Other trials in Taiwan

Malaysia2 sites

  • Hospital Ampang ( Site 3202)

    Ampang, Selangor, 68000

  • Hospital Sultanah Aminah ( Site 3203)

    Johor Bahru, Johor, 80100

Other trials in Malaysia

Singapore2 sites

  • National Cancer Centre Singapore ( Site 4200)

    Singapore, Central Singapore, 168583

  • Tan Tock Seng Hospital ( Site 4202)

    Singapore, Central Singapore, 308433

Other trials in Singapore

Australia1 site

  • Royal Adelaide Hospital ( Site 1105)

    Adelaide, South Australia, 5000

Other trials in Australia

Hong Kong1 site

  • Queen Mary Hospital ( Site 2500)

    Hksar

Other trials in Hong Kong

Lithuania1 site

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3100)

    Kaunas, Kaunas County, 50161

Other trials in Lithuania

About this study

Official title: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations

Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).

Being tested
Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NemtabrutinibDrug

    Also called MK-1026, ARQ 531

    65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met.

  • FludarabineDrug

    25 mg/m^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.

  • CyclophosphamideDrug

    250 mg/m^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.

  • BendamustineDrug

    Administered via IV infusion on Days 1 and 2 of each 28-day cycle up to 6 cycles. The first dose is given as 70 to 90 mg/m^2. Subsequent doses may be escalated up to 90 mg/m^2, if applicable and as per local guidelines.

  • RituximabBiological

    Also called RITUXAN®/MabThera

    Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m^2 (cycle 1) followed by 500 mg/m^2 for remaining cycles.

  • TruximaBiological

    Also called Rituximab biosimilar

    Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m^2 (cycle 1) followed by 500 mg/m^2 for remaining cycles.

  • RuxienceBiological

    Also called Rituximab biosimilar

    Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m^2 (cycle 1) followed by 500 mg/m^2 for remaining cycles.

  • RiabniBiological

    Also called Rituximab biosimilar

    Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m^2 (cycle 1) followed by 500 mg/m^2 for remaining cycles.

Study groups in NCT05624554
Study groupRoleWhat they receive
NemtabrutinibExperimentalAdministered daily via oral tablet.
Receives: Drug: Nemtabrutinib
FCR or BRActive comparatorInvestigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine; Biological: Rituximab; Biological: Truxima; Biological: Ruxience; Biological: Riabni

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR).

    Measured: Up to approximately 49 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 94 months

  2. Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR

    ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or Partial response (PR), per iwCLL criteria 2018 as assessed by BICR.

    Measured: Up to approximately 36 months

  3. Time to Next Therapy (TTNT)

    TTNT is defined as the time from randomization to initiation of the first dose of a new systemic anticancer therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 94 months

  4. Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR

    For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL criteria as assessed by BICR, DOR is 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.

    Measured: Up to approximately 94 months

  5. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 94 months

  6. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 94 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start16 Mar 2023
  3. Primary completion19 May 2027 (estimated)
  4. Study completion17 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624554
Sponsor's protocol ID
1026-008
Other IDs
2022-501481-21-00, MK-1026-008, U1111-1274-2574, 2021-006593-23
Status last verified
Mar 2026
First submitted
14 Nov 2022
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Davids MS. BRUIN 313 and 314 Trials Open the Door for Noncovalent Bruton Tyrosine Kinase Inhibition as Initial Therapy for Chronic Lymphocytic Leukemia. J Clin Oncol. 2026 Feb 20;44(6):435-439. doi: 10.1200/JCO-25-02691. Epub 2025 Dec 9.

    PubMed 41363770

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nemtabrutinib, Fludarabine and Cyclophosphamide in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC at 97 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in China, Brazil, Chile, Poland, Ukraine and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 49 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624554, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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