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 17 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
Medical Oncology Associates, PS ( Site 5406)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
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
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)
St Albans Victoria, 3021, Australia More Info
Study Coordinator
Contact
61395944044
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
FALP-UIDO ( Site 1500)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
+56984290128
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 , 52621, Israel More Info
Study Coordinator
Contact
972526669155
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

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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