Phase
Condition
Lymphoproliferative Disorders
Lymphocytic Leukemia, Chronic
Chronic Lymphocytic Leukemia
Treatment
Sonrotoclax
Zanubrutinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
CLL requiring treatment as per pre-defined criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
Measurable disease by CT/MRI.
Adequate marrow function.
Adequate liver function as indicated by aspartate aminotransferase (AST) alanineaminotransferase (ALT) and serum total bilirubin.
Adequate renal function.
Life expectancy > 6 months.
Signed informed consent and able to comply with the study protocol in theinvestigator's judgment.
Women of childbearing potential must be willing to use a highly effective method ofbirth control for the duration of the study and for ≥ 90 days after the last dose ofstudy drug.
Exclusion
Exclusion Criteria:
Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation
Known central nervous system involvement
Received previous systemic treatment for CLL
Clinically significant cardiovascular disease
Severe or debilitating pulmonary disease
History of prior malignancy
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitisB or C infection
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiringtreatment
History of severe bleeding disorder such as hemophilia A, hemophilia B, vonWillebrand disease, or history of spontaneous bleeding requiring blood transfusionor other medical intervention
History of stroke or intracranial hemorrhage ≤ 6 months before the first dose ofstudy treatment
Unable to swallow capsules or tablets or diseases significantly affecting GIfunction
Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
Use of investigational agents within the last 4 weeks before screening
Pregnant and lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Centro de Pesquisas Oncologicas Cepon
Florianopolis, 88034-000
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, 900350-903
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, 900350-903
BrazilSite Not Available
Instituto Dor de Pesquisa E Ensino Sao Paulo
Sao Paulo, 01401-002
BrazilActive - Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo, 05653-120
BrazilActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaSite Not Available
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu 213000
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200025
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123
ItalySite Not Available
Aou Careggi, Servizio Sanitario Toscana
Firenze, 50134
ItalySite Not Available
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, 41124
ItalySite Not Available
Aoor Villa Sofia Cervello
Palermo, 90146
ItalySite Not Available
Pratia Onkologia Katowice
Katowice, 40-055
PolandSite Not Available
Pratia McM Krakow
Krakow, 30-727
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Nr W Lublinie
Lublin, 20-090
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Hematology
Wroclaw, 50-367
PolandSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital de Cabuenes
Gijon, 33394
SpainSite Not Available
Clinica Universidad de Navarra
Madrid, 28027
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Clinica Universidad de Navarra Pamplona
Pamplona, 31008
SpainSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia 30060
United StatesActive - Recruiting
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois 60714
United StatesSite Not Available
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
Nebraska Cancer Specialists
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Nebraska Cancer Specialists (Satellite Site)
Grand Island, Nebraska 68803
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Summit Medical Group
Florham Park, New Jersey 07932
United StatesActive - Recruiting
New York Cancer and Blood Specialists
Shirley, New York 11967
United StatesSite Not Available
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon 97401
United StatesSite Not Available
Texas Oncology Dfw
Dallas, Texas 96817
United StatesSite Not Available
Texas Oncology Tyler
Tyler, Texas 75702
United StatesSite Not Available
Utah Cancer Specialists
Sandy, Utah 08106
United StatesSite Not Available
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington 98684
United StatesSite Not Available
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