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New drug combo aims to outperform standard therapy for Hard-to-Treat blood cancers

NCT ID NCT05947851

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 12 times

Summary

This phase 3 trial is testing whether a new drug, nemtabrutinib, combined with venetoclax works better than the current standard of venetoclax plus rituximab for people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). About 735 participants who have already tried at least one prior therapy will be randomly assigned to one of the two treatment groups. The main goal is to see if the new combination improves how long people live without their cancer getting worse.

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 cancer drug) combined with venetoclax (another targeted cancer drug)
What this could lead to
If successful, this combination could offer a more effective treatment option for people with relapsed or refractory CLL/SLL, potentially slowing disease progression better than current therapies.
What could go wrong
This is an early-stage combination study, so safety and effectiveness are not yet proven. Side effects may include serious toxicities, and the new drug may not work better than existing treatments.

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 735 people

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

Started

Aug 2023

Expected to finish

Jul 2035

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.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

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

CLL Leukemia, chronic lymphocytic Leukemia, lymphocytic, chronic, B-cell Lymphoma, small lymphocytic SLL Small-cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    64 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alberts Cellular Therapy. ( Site 4401)

    RECRUITING

    Pretoria, Gauteng, 0181, South Africa

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

    COMPLETED

    Ankara, 06100, Turkey (Türkiye)

  • Arcispedale Santa Maria Nuova-Hematology ( Site 2900)

    RECRUITING

    Reggio Emilia, 42123, Italy

  • Auxilio Mutuo Cancer Center ( Site 3900)

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Avera Cancer Institute- Research ( Site 5437)

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906)

    RECRUITING

    Alessandria, 15121, Italy

  • Biocenter ( Site 1507)

    RECRUITING

    Concepción, Biobio, 4070196, Chile

  • Box Hill Hospital ( Site 1106)

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • CHD Vendee ( Site 2100)

    RECRUITING

    La Roche-sur-Yon, Vendee, 85925, France

  • Center for Cancer and Blood Disorders ( Site 5439)

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Centre Hospitalier Universitaire Estaing ( Site 2105)

    RECRUITING

    Clermont-Ferrand, Puy-de-Dome, 63100, France

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402)

    RECRUITING

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410)

    RECRUITING

    Sherbrooke, Quebec, J1H 5H4, Canada

  • Centro Medico Fleischer ( Site 1006)

    RECRUITING

    Buenos Aires, 1414, Argentina

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002)

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina

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

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Centro de Infusion Superare ( Site 3314)

    RECRUITING

    Mexico City, Mexico City, 03100, Mexico

  • Centro de Investigacion Clinica Chapultepec ( Site 3309)

    RECRUITING

    Morelia, Michoacán, 58260, Mexico

  • City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)

    RECRUITING

    Nottingham, England, NG5 1PF, United Kingdom

  • Clínica Inmunocel ( Site 1511)

    RECRUITING

    Santiago, Region M. de Santiago, 7580206, Chile

  • Ege Universitesi Hastanesi ( Site 4902)

    RECRUITING

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • FALP-UIDO ( Site 1500)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fort Wayne Medical Oncology and Hematology ( Site 5444)

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Fundación Valle del Lili ( Site 1703)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Groote Schuur Hospital ( Site 4400)

    RECRUITING

    Cape Town, Western Cape, 7925, South Africa

  • HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)

    RECRUITING

    Valencia, Valenciana, Comunitat, 46010, Spain

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hadassah Medical Center-Hemato-Oncology ( Site 2812)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Haemalife ( Site 4407)

    RECRUITING

    Kuilsriver, Western Cape, 7580, South Africa

  • Hattiesburg Clinic Hematology/Oncology ( Site 5416)

    RECRUITING

    Hattiesburg, Mississippi, 39401, United States

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

    RECRUITING

    Mexico City, Mexico City, 03100, Mexico

  • Highlands Oncology Group ( Site 5405)

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hopital Claude Huriez - CHU de Lille ( Site 2107)

    RECRUITING

    Lille, Nord, 59037, France

  • Hospital Aleman-oncohematologic diseases ( Site 1001)

    RECRUITING

    Buenos Aires, C1118AAT, Argentina

  • IC La Serena Research ( Site 1506)

    RECRUITING

    La Serena, Coquimbo Region, 1720430, Chile

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

    ACTIVE_NOT_RECRUITING

    São Paulo, 01246-000, Brazil

  • Instituto Alexander Fleming ( Site 1005)

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)

    RECRUITING

    L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 5433)

    RECRUITING

    Billings, Montana, 59102, United States

  • Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)

    RECRUITING

    Trier, Rhineland-Palatinate, 54290, Germany

  • Medical Oncology Associates, PS ( Site 5406)

    RECRUITING

    Spokane, Washington, 99208, United States

  • Mega Medipol-Hematology ( Site 4904)

    RECRUITING

    Istanbul, 34214, Turkey (Türkiye)

  • Memorial Hospital West ( Site 5410)

    RECRUITING

    Pembroke Pines, Florida, 33028, United States

  • MemorialCare Health System - Long Beach Medical Center ( Site 5421)

    RECRUITING

    Long Beach, California, 90806, United States

  • MidAmerica Cancer Care, LLC ( Site 5426)

    RECRUITING

    Kansas City, Missouri, 64132, United States

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

    RECRUITING

    Tekirdağ, Tekirdas, 59100, Turkey (Türkiye)

  • New York Oncology Hematology, P.C. ( Site 5453)

    RECRUITING

    Albany, New York, 12208, United States

  • Oregon Health and Science University ( Site 5425)

    RECRUITING

    Portland, Oregon, 97239-3011, United States

  • Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)

    RECRUITING

    Milan, 20132, Italy

  • PatientCare Clinical Research LLC ( Site 5435)

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Rambam Health Care Campus ( Site 2801)

    RECRUITING

    Haifa, 3109601, Israel

  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 5434)

    RECRUITING

    Reno, Nevada, 89502, United States

  • Royal Adelaide Hospital ( Site 1104)

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Sanatorio Parque ( Site 1003)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Sheba Medical Center-Hemato Oncology ( Site 2809)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 2811)

    RECRUITING

    Tel Aviv, 6423906, Israel

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

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • The Moncton Hospital ( Site 1414)

    RECRUITING

    Moncton, New Brunswick, E1C 6Z8, Canada

  • UZ Leuven-Hematology ( Site 1200)

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)

    RECRUITING

    London-Camden, London, City of, NW1 2PG, United Kingdom

  • University of Virginia Cancer Center ( Site 5402)

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)

    COMPLETED

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Vista Oncology ( Site 5449)

    RECRUITING

    Olympia, Washington, 98506, United States

  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)

    RECRUITING

    Melbourne, Victoria, 3021, Australia

  • ZAS Cadix ( Site 1203)

    RECRUITING

    Antwerp, 2030, Belgium

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