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Active (not recruiting) Phase 3 NCT05624554

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Phase 3 – large-scale trial before approval
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).
Who can participate
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
Locations 21
Australia (1)
Royal Adelaide Hospital ( Site 1105)
Adelaide , South Australia
Brazil (1)
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1317)
Curitiba , Paraná
Bulgaria (1)
Specialized Hospital for Active Treatment of Haematology Diseases ( Site 6403)
Sofia , Sofia (stolitsa)
Chile (1)
James Lind Centro de Investigacion del Cancer ( Site 1503)
Temuco , Araucania
China (1)
Peking University Third Hospital ( Site 1602)
Beijing , Beijing Municipality
Colombia (1)
Clini Salud ( Site 1700)
Envigado , Antioquia
Denmark (1)
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 1902)
Aarhus , Central Jutland
Guatemala (1)
MEDI-K ( Site 2401)
Guatemala City
Hong Kong (1)
Queen Mary Hospital ( Site 2500)
Hksar
Hungary (1)
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
Székesfehérvár , Fejér
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Oncology and Hematology ( Site 3100)
Kaunas , Kaunas County
Malaysia (1)
Hospital Sultanah Aminah ( Site 3203)
Johor Bahru , Johor
Mexico (1)
Centro de Infusion Superare ( Site 3314)
Mexico City , Mexico City
Poland (1)
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie ( Site 3710)
Lublin , Lublin Voivodeship
Romania (1)
Spitalul Clinic Colțea ( Site 4000)
Bucharest , Bucharest
Singapore (1)
National Cancer Centre Singapore ( Site 4200)
Singapore , Central Singapore
South Africa (1)
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Centurion , Gauteng
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700)
Kaohsiung City
Turkey (1)
Mega Medipol-Hematology ( Site 4904)
Stanbul , Istanbul
Ukraine (1)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 5106)
Cherkassy , Cherkasy Oblast
United States (1)
Highlands Oncology Group ( Site 5205)
Springdale , Arkansas
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.03.2023
Completion date
17.03.2031
Registry ID
NCT05624554
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.