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New pill could outshine chemo for blood cancer patients

NCT ID NCT05624554

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares the experimental drug nemtabrutinib (a daily pill) against standard chemotherapy combinations for people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who lack a specific genetic change (TP53 mutation). About 300 participants will be randomly assigned to receive either nemtabrutinib or chemoimmunotherapy. The main goal is to see if nemtabrutinib helps patients live longer without their cancer worsening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nemtabrutinib (a targeted oral drug)
What this could lead to
If successful, this could offer a more effective, chemotherapy-free option for people with untreated CLL/SLL, potentially delaying disease progression.
What could go wrong
This is an early-phase 3 trial, so results are not yet confirmed. Nemtabrutinib may not prove superior to standard treatments, and side effects like infections or bleeding are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

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

    São Paulo, São Paulo, 01525-001, Brazil

  • Aalborg Universitetshospital, Syd ( Site 1901)

    Aalborg, North Denmark, 9000, Denmark

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)

    Aarhus, Central Jutland, 8200, Denmark

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

    Ankara, 06100, Turkey (Türkiye)

  • Biocenter ( Site 1507)

    Concepción, Biobio, 4070196, Chile

  • CELAN,S.A ( Site 2403)

    Guatemala City, 01010, Guatemala

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

    Santiago, Region M. de Santiago, 7500653, Chile

  • Centro de Infusion Superare ( Site 3314)

    Mexico City, Mexico City, 03100, Mexico

  • Centro de Investigacion Clinica Chapultepec ( Site 3309)

    Morelia, Michoacán, 58260, Mexico

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

    Kaohsiung City, 83301, Taiwan

  • Chongqing University Cancer Hospital ( Site 1605)

    Chongqing, Chongqing Municipality, 400030, China

  • Chongqing University Three Gorges Hospital ( Site 1609)

    Chongqing, Chongqing Municipality, 404000, China

  • Clermont Oncology Center ( Site 5224)

    Clermont, Florida, 34711, United States

  • Clini Salud ( Site 1700)

    Envigado, Antioquia, 055422, Colombia

  • Clínica Inmunocel ( Site 1511)

    Santiago, Region M. de Santiago, 7580206, Chile

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

  • Constantiaberg Haematology ( Site 4408)

    Plumstead, Western Cape, 7800, South Africa

  • Ege Universitesi Hastanesi ( Site 4902)

    Izmir, 35100, Turkey (Türkiye)

  • FALP-UIDO ( Site 1500)

    Santiago, Region M. de Santiago, 7500921, Chile

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

    Székesfehérvár, Fejér, 8000, Hungary

  • Fudan University Shanghai Cancer Center ( Site 1606)

    Shanghai, Shanghai Municipality, 200032, China

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707)

    Medellín, Antioquia, 050030, Colombia

  • Groote Schuur Hospital-Clinical Haematology ( Site 4400)

    Cape Town, Western Cape, 7925, South Africa

  • Haemalife ( Site 4407)

    Kuilsriver, Western Cape, 7580, South Africa

  • Hainan General Hospital ( Site 1603)

    Haikou, Hainan, 570311, China

  • Hattiesburg Clinic Hematology/Oncology ( Site 5216)

    Hattiesburg, Mississippi, 39401, United States

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

    Mexico City, Mexico City, 03100, Mexico

  • Henan Cancer Hospital-hematology department ( Site 1613)

    Zhengzhou, Henan, 450008, China

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

    Eger, Heves County, 3300, Hungary

  • Highlands Oncology Group ( Site 5205)

    Springdale, Arkansas, 72762, United States

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

    Jaú, São Paulo, 17210-120, Brazil

  • Hospital Ampang ( Site 3202)

    Ampang, Selangor, 68000, Malaysia

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

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Paulistano-Americas Oncologia ( Site 1302)

    São Paulo, 01321-001, Brazil

  • Hospital Sultanah Aminah ( Site 3203)

    Johor Bahru, Johor, 80100, Malaysia

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

    Kaunas, Kaunas County, 50161, Lithuania

  • Hunan Cancer Hospital ( Site 1615)

    Changsha, Hunan, 410013, China

  • IC La Serena Research ( Site 1506)

    La Serena, Coquimbo Region, 1720430, Chile

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

    São Paulo, 01246-000, Brazil

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

    Lviv, Lviv Oblast, 79057, Ukraine

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

    Tianjin, Tianjin Municipality, 300020, China

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

    Rio de Janeiro, 20231-050, Brazil

  • Institutul Oncologic Cluj ( Site 4002)

    Cluj-Napoca, 400015, Romania

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

    Temuco, Araucania, 4800827, Chile

  • Jiangxi Provincial Cancer Hospital ( Site 1628)

    Nanchang, Jiangxi, 330029, China

  • MEDI-K ( Site 2401)

    Guatemala City, 01009, Guatemala

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

    Cherkassy, Cherkasy Oblast, 18009, Ukraine

  • Medical Centre Pratia Clinic EOOD ( Site 6406)

    Plovdiv, 4003, Bulgaria

  • Medical Oncology Associates, PS ( Site 5206)

    Spokane, Washington, 99208, United States

  • Mega Medipol-Hematology ( Site 4904)

    Stanbul, Istanbul, 34214, Turkey (Türkiye)

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

    Vratsa, 3000, Bulgaria

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

    Suleymanpasa, Tekirdas, 59100, Turkey (Türkiye)

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Centre Singapore ( Site 4200)

    Singapore, Central Singapore, 168583, Singapore

  • National Cheng Kung University Hospital ( Site 4701)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 4704)

    Taipei, 10002, Taiwan

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

    Centurion, Gauteng, 0181, South Africa

  • Nonprofit Organization National Cancer Institute ( Site 5103)

    Kyiv, Kyivska Oblast, 03022, Ukraine

  • Oaxaca Site Management Organization ( Site 3313)

    Oaxaca City, 68000, Mexico

  • Odense Universitetshospital ( Site 1900)

    Odense C, Region Syddanmark, 5000, Denmark

  • Oncologos del Occidente ( Site 1706)

    Pereira, Risaralda Department, 660001, Colombia

  • Oncomedica ( Site 2402)

    Guatemala City, 01010, Guatemala

  • Peking University Third Hospital ( Site 1602)

    Beijing, Beijing Municipality, 100191, China

  • Pratia Onkologia Katowice ( Site 3705)

    Katowice, Silesian Voivodeship, 40-519, Poland

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

    Kyiv, 04112, Ukraine

  • Queen Mary Hospital ( Site 2500)

    Hksar, Hong Kong

  • Royal Adelaide Hospital ( Site 1105)

    Adelaide, South Australia, 5000, Australia

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

    Kyiv, 03115, Ukraine

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

    Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

  • Shaanxi provincial people's hospital ( Site 1626)

    Xi'an, Shaanxi, 710068, China

  • Shanxi Cancer Hospital ( Site 1629)

    Taiyuan, Shanxi, 030000, China

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

    Valledupar, Cesar Department, 200001, Colombia

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

    Guangzhou, Guangdong, 510515, China

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

    Sofia, Sofia (stolitsa), 1797, Bulgaria

  • Spitalul Clinic Colțea ( Site 4000)

    Bucharest, Bucharest, 030171, Romania

  • Spitalul Clinic Colțea ( Site 4001)

    Bucharest, Bucharest, 030171, Romania

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

    Guangzhou, Guangdong, 510700, China

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

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

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

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

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

    Istanbul, 34722, Turkey (Türkiye)

  • Tan Tock Seng Hospital ( Site 4202)

    Singapore, Central Singapore, 308433, Singapore

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

    Guiyang, Guizhou, 550004, China

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

    Nanchang, Jiangxi, 330006, China

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

    Suzhou, Jiangsu, 215006, China

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

    Xi'an, Shaanxi, 710061, China

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

    Hangzhou, Zhejiang, 310003, China

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

    Changchun, Jilin, 130021, China

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

    Tianjin, Tianjin Municipality, 300060, China

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

    Wuhan, Hubei, 430000, China

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

    Stara Zagora, 6003, Bulgaria

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

    Wuhan, Hubei, 430022, China

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

    Plovdiv, 4002, Bulgaria

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

    Lublin, Lublin Voivodeship, 20-081, Poland

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

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Vejle Sygehus ( Site 1903)

    Vejle, Region Syddanmark, 7100, Denmark

  • Wits Clinical Research ( Site 4403)

    Johannesburg, Gauteng, 1864, South Africa

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

    Changsha, Hunan, 410008, China

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