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Clinical Trials in Turkey / NCT05947851
Recruiting Phase 3

A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

NCT05947851 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 3
Started
2023-08-08
Last updated
2026-09-24

Condition(s) studied

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Chronic LymphocyticSmall-Cell LymphomaLymphoma, Small LymphocyticCLLSLL

Investigational drug(s) / intervention(s)

Nemtabrutinib →Venetoclax →Rituximab →

Nemtabrutinib: 5, 20, and 45 tablets

Venetoclax: 10, 50, and 100 mg tablets

Rituximab: 100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

Study summary

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy * Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only * Relapsed or refractory to at least 1 prior available therapy * Have at least 1 marker of disease burden * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization * Has a life expectancy of at least 3 months * Has the ability to swallow and retain oral medication * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening * Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria * Participants with adequate organ function with specimens collected within 7 days before the start of study intervention * If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception * Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding Exclusion Criteria: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection * Has gastrointestinal (GI) dysfunction that may affect drug absorption * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL * Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening * Clinically significant cardiovascular disease * Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients * Has history of severe bleeding disorders (eg, hemophilia) * Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization * Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids * Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors. * Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration * Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Highlands Oncology Group ( Site 5405) Springdale Arkansas Recruiting
MemorialCare Health System - Long Beach Medical Center ( Site 5421) Long Beach California Recruiting
Clermont Oncology Center ( Site 5430) Clermont Florida Recruiting
Memorial Hospital West ( Site 5410) Pembroke Pines Florida Recruiting
Fort Wayne Medical Oncology and Hematology ( Site 5444) Fort Wayne Indiana Recruiting
Center for Cancer and Blood Disorders ( Site 5439) Bethesda Maryland Recruiting
Hattiesburg Clinic Hematology/Oncology ( Site 5416) Hattiesburg Mississippi Recruiting
MidAmerica Cancer Care, LLC ( Site 5426) Kansas City Missouri Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 5433) Billings Montana Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 5434) Reno Nevada Recruiting
New York Oncology Hematology, P.C. ( Site 5453) Albany New York Recruiting
Oregon Health and Science University ( Site 5425) Portland Oregon Recruiting
Avera Cancer Institute- Research ( Site 5437) Sioux Falls South Dakota Recruiting
PatientCare Clinical Research LLC ( Site 5435) Sugar Land Texas Recruiting
University of Virginia Cancer Center ( Site 5402) Charlottesville Virginia Recruiting
Vista Oncology ( Site 5449) Olympia Washington Recruiting
Medical Oncology Associates, PS ( Site 5406) Spokane Washington Recruiting
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423) Madison Wisconsin Completed
Instituto Alexander Fleming ( Site 1005) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007) Mar del Plata Buenos Aires Recruiting
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002) Buenos Aires Buenos Aires F.D. Recruiting
Sanatorio Parque ( Site 1003) Rosario Santa Fe Province Recruiting
Centro Medico Fleischer ( Site 1006) Buenos Aires Argentina Recruiting
Hospital Aleman-oncohematologic diseases ( Site 1001) Buenos Aires Argentina Recruiting
Royal Adelaide Hospital ( Site 1104) Adelaide South Australia Recruiting
Box Hill Hospital ( Site 1106) Box Hill Victoria Recruiting
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103) Melbourne Victoria Recruiting
UZ Leuven-Hematology ( Site 1200) Leuven Vlaams-Brabant Recruiting
ZAS Cadix ( Site 1203) Antwerp Belgium Recruiting
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) São Paulo Brazil Active Not Recruiting
The Moncton Hospital ( Site 1414) Moncton New Brunswick Recruiting
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402) Greenfield Park Quebec Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410) Sherbrooke Quebec Recruiting
Biocenter ( Site 1507) Concepción Biobio Recruiting
IC La Serena Research ( Site 1506) La Serena Coquimbo Region Recruiting
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) Santiago Region M. de Santiago Recruiting
FALP-UIDO ( Site 1500) Santiago Region M. de Santiago Recruiting
Clínica Inmunocel ( Site 1511) Santiago Region M. de Santiago Recruiting
Fundación Valle del Lili ( Site 1703) Cali Valle del Cauca Department Recruiting
Hopital Claude Huriez - CHU de Lille ( Site 2107) Lille Nord Recruiting

+ 39 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile → 📄 Rituxan (rituximab) drug profile →

More Merck Sharp & Dohme LLC trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05947851 on ClinicalTrials.gov ↗ ← All trials in Turkey