Chronic Lymphocytic Leukemia Clinical Trial

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)

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 leukemia-cll/" >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).

View Eligibility Criteria

Eligibility Criteria

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, immunoglobulin heavy chain gene (IGHV) mutation status and Bruton's tyrosine kinase (BTK)-C481 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 3 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.
Has QT interval corrected (QTc) prolongation or other significant electrocardiogram (ECG) abnormalities.
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) including venetoclax or Non-covalent Bruton's tyrosine kinase inhibitor (BTKi).
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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

720

Study ID:

NCT05947851

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 40 Locations for this study

See Locations Near You

Highlands Oncology Group ( Site 5405)
Springdale Arkansas, 72762, United States More Info
Study Coordinator
Contact
479-872-8130
MemorialCare Health System - Long Beach Medical Center ( Site 5421)
Long Beach California, 90806, United States More Info
Study Coordinator
Contact
562-933-1877
Memorial Hospital West ( Site 5410)
Pembroke Pines Florida, 33028, United States More Info
Study Coordinator
Contact
786-333-9982
Medical Oncology Associates, PS ( Site 5406)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)
Madison Wisconsin, 53792, United States More Info
Study Coordinator
Contact
608-262-9317
Instituto Alexander Fleming ( Site 1005)
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina More Info
Study Coordinator
Contact
+5491140510781
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007)
Mar del Plata Buenos Aires, B7600, Argentina More Info
Study Coordinator
Contact
+5492235937663
Hospital Aleman-oncohematologic diseases ( Site 1001)
Buenos Aires Caba, C1118, Argentina More Info
Study Coordinator
Contact
+5491153857234
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002)
Buenos Aires Caba, C1431, Argentina More Info
Study Coordinator
Contact
+5491159785130
Sanatorio Parque ( Site 1003)
Rosario Santa Fe, S2000, Argentina More Info
Study Coordinator
Contact
5493416149812
Centro Medico Fleischer ( Site 1006)
Buenos Aires , 1414, Argentina More Info
Study Coordinator
Contact
05491164901040
Royal Adelaide Hospital ( Site 1104)
Adelaide South Australia, 5000, Australia More Info
Study Coordinator
Contact
61-8-8222-6934
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103)
Melbourne Victoria, 3021, Australia More Info
Study Coordinator
Contact
61395944044
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308)
São Paulo Sao Paulo, 01246, Brazil More Info
Study Coordinator
Contact
+5511999014316
The Moncton Hospital ( Site 1414)
Moncton New Brunswick, E1C 6, Canada More Info
Study Coordinator
Contact
506-870-2404
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke Quebec, J1H 5, Canada More Info
Study Coordinator
Contact
819-346-1110 ext 12811
Biocenter ( Site 1507)
Concepción Biobio, 40701, Chile More Info
Study Coordinator
Contact
956284078
IC La Serena Research ( Site 1506)
La Serena Coquimbo, 17204, Chile More Info
Study Coordinator
Contact
+56951280903
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509)
Santiago Region M. De Santiago, 75006, Chile More Info
Study Coordinator
Contact
+56991612199
FALP-UIDO ( Site 1500)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
+56984290128
Clínica Inmunocel ( Site 1511)
Santiago Region M. De Santiago, 75802, Chile More Info
Study Coordinator
Contact
997890202
Fundación Valle del Lili ( Site 1703)
Cali Valle Del Cauca, 76003, Colombia More Info
Study Coordinator
Contact
23319090
Centre Hospitalier Universitaire Estaing ( Site 2105)
Clermont-Ferrand Puy-de-Dome, 63100, France More Info
Study Coordinator
Contact
33473750065
CHD Vendee ( Site 2100)
La Roche-sur-Yon Vendee, 85925, France More Info
Study Coordinator
Contact
0251446173
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203)
Trier Rheinland-Pfalz, 54290, Germany More Info
Study Coordinator
Contact
0049 651 947 2571
Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201)
Leipzig Sachsen, 04103, Germany More Info
Study Coordinator
Contact
03419713858
Rambam Health Care Campus ( Site 2801)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247772541
Hadassah Medical Center-Hemato-Oncology ( Site 2812)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226778180
Sheba Medical Center-Hemato Oncology ( Site 2809)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
972526669155
Sourasky Medical Center ( Site 2811)
Tel Aviv , 64239, Israel More Info
Study Coordinator
Contact
97236973782
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria , 15121, Italy More Info
Study Coordinator
Contact
+390131206440
Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902)
Milano , 20132, Italy More Info
Study Coordinator
Contact
+390226436119
Arcispedale Santa Maria Nuova-Hematology ( Site 2900)
Reggio Emilia , 42123, Italy More Info
Study Coordinator
Contact
3474890239
Auxilio Mutuo Cancer Center ( Site 3900)
San Juan , 00918, Puerto Rico More Info
Study Coordinator
Contact
7877582000
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 4401)
Moreletta Park Gauteng, 0181, South Africa More Info
Study Coordinator
Contact
27129932555
Haemalife ( Site 4407)
Kuilsriver Western Cape, 7580, South Africa More Info
Study Coordinator
Contact
+27219006277
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601)
L'Hospitalet Del Llobregat Barcelona, 08908, Spain More Info
Study Coordinator
Contact
+34932607750
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
914521900
HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603)
Valencia Valenciana, Comunitat, 46010, Spain More Info
Study Coordinator
Contact
961973930
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
Nottingham England, NG5 1, United Kingdom More Info
Study Coordinator
Contact
447425788152

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

720

Study ID:

NCT05947851

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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