New pill combo aims to improve leukemia control without chemo
NCT ID NCT06637501
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?