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)
- Trial number:
- NCT05624554
- Trial phase:
- 3
- Study type:
- Any
- Overall status:
- Recruiting
Study start date
March, 2023
Scientific title
A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations
Summary
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).
The main inclusion and exclusion criteria include but are not limited to the following:
* 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
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Masking:
SINGLE, Subject masked:
No, Caregiver masked:
No, Investigator masked:
No, Outcomes assessor masked:
Yes,
Conditions
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Other study ID numbers
2022-501481-21-00; MK-1026-008; U1111-1274-2574; 2021-006593-23; 1026-008
Choose trial site (124)
Royal Adelaide Hospital ( Site 1105)
Adelaide SA, Australia
Hospital Amaral Carvalho-Centro de Pesquisas ( Site 1304)
R. Doná Silvéria, 150 - Chácara Braz Miraglia, Jaú - SP, 17210-070, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo - SP, 01246-000, Brazil
Hospital Paulistano-Americas Oncologia ( Site 1302)
R. Martiniano de Carvalho, 741 - Bela Vista, São Paulo - SP, 01321-001, Brazil
Biocenter ( Site 1507)
4070196 Concepción, Bio Bio, Chile
IC La Serena Research ( Site 1506)
1720430 La Serena, Coquimbo, Chile
FALP-UIDO ( Site 1500)
Santiago, Santiago Metropolitan Region, Chile
Institute of hematology&blood disease hospital-Hematology ( Site 1600)
Heping, China, 300020
Aalborg Universitetshospital, Syd ( Site 1901)
Hobrovej 18-22, 9000 Aalborg, Denmark
Odense Universitetshospital ( Site 1900)
Odense, Denmark
Vejle Sygehus ( Site 1903)
Vejle, Denmark
CELAN,S.A ( Site 2403)
Guatemala City, Guatemala
Oncomedica-Guatemala ( Site 2402)
Guatemala
MEDI-K CAYALA ( Site 2401)
Guatemala City, Guatemala
Queen Mary Hospital ( Site 2500)
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
Fejér Megyei Szent György Egyetemi Oktató Kórház ( Site 2609)
Székesfehérvár, Seregélyesi út 3, 8000 Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet ( Site 2608)
Eger, Markhót Ferenc u. 1, 3300 Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 2602)
Nyíregyháza, Hungary
Hospital Sultanah Aminah ( Site 3203)
Jalan, Persiaran Abu Bakar Sultan, 80100 Johor Bahru, Johor, Malaysia
Hospital Ampang ( Site 3202)
Jalan Mewah Utara, Taman Pandan Mewah, 68000 Ampang, Selangor, Malaysia
Samodzielny Publiczny Szpital Kliniczny nr 1-Department of Haematooncology and Bone Marrow Transpla
Lublin, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
park Marii Skłodowskiej-Curie, Warszawa, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 3702)
Gdańsk, Poland
Pratia Onkologia Katowice ( Site 3705)
Tadeusza Kościuszki 92, 40-519 Katowice, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmi-Oddzial Kliniczny Hematologii ( Site 37
Olsztyn, Poland
National Cancer Centre Singapore
30 Hospital Blvd, Singapore 168583
Tan Tock Seng Hospital Singapore
11 Jln Tan Tock Seng, Singapore 308433
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Centurion, South Africa
National Taiwan University Hospital ( Site 4704)
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Mega Medipol-Hematology ( Site 4904)
TEM Avrupa otoyolu göztepe çıkışı no:1, Göztepe, 34214 Bağcılar/İstanbul, Türkiye
Namik Kemal University Medical Faculty-Hematology ( Site 4912)
Namık Kemal Kampüs Cad No:1, Namık Kemal, 59030 Süleymanpaşa/Tekirdağ, Türkiye
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913)
Ankara, Türkiye
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906)
Eğitim, Göztepe Araştırma Hst., 34722 Kadıköy/İstanbul, Türkiye
Ege Universitesi Hastanesi ( Site 4902)
Kazımdirik, Ege Ünv. Ögrenci Köyü İç Yol, 35100 Bornova/İzmir, Türkiye