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New pill combo aims to improve leukemia control without chemo

NCT ID NCT06637501

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether adding sonrotoclax to the standard drug zanubrutinib works better than zanubrutinib alone for adults with untreated chronic lymphocytic leukemia (CLL). About 94 participants will receive either the combination or the single drug. The goal is to see if the combo leads to more complete remissions and undetectable cancer levels.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 94 people

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

Started

Nov 2024

Expected to finish

Sep 2029

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: 1. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL. 2. CLL requiring treatment as per pre-defined criteria. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2. 4. Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI). 5. Adequate marrow function. 6. Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin. 7. Adequate renal function. 8. Life expectancy \> 6 months. 9. Signed informed consent and able to comply with the study protocol in the investigator's judgment. 10. Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug. Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Known central nervous system involvement 3. Received previous systemic treatment for CLL 4. Clinically significant cardiovascular disease 5. Severe or debilitating pulmonary disease 6. History of prior malignancy 7. Active fungal, bacterial, and/or viral infection requiring systemic therapy 8. Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection 9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment 10. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment 12. Unable to swallow capsules or tablets or diseases significantly affecting GI function 13. Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients 14. Use of investigational agents within the last 4 weeks before screening 15. Pregnant and lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Aoor Villa Sofia Cervello

    Palermo, 90146, Italy

  • Aou Careggi, Servizio Sanitario Toscana

    Florence, 50134, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Centro de Pesquisas Oncologicas Cepon

    Florianópolis, 88034-000, Brazil

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609, United States

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital de Cabuenes

    Gijón, 33394, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903, Brazil

  • Illinois Cancer Specialists (Niles) Usor

    Niles, Illinois, 60714-5905, United States

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004, Brazil

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042, United States

  • Nebraska Cancer Specialists (Satellite Site)

    Omaha, Nebraska, 68130-2042, United States

  • Northwest Georgia Oncology Centers Marietta

    Marietta, Georgia, 30060-1152, United States

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon, 97401, United States

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Pratia Onkologia Katowice

    Katowice, 40-519, Poland

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900, Brazil

  • Texas Oncology Dfw

    Dallas, Texas, 75231-7001, United States

  • Texas Oncology Tyler

    Tyler, Texas, 75702-7522, United States

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000, China

  • The University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124, Italy

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367, Poland

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090, Poland

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.