Chronic Lymphocytic Leukemia Clinical Trial

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator’s Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Summary

The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with leukemia-cll/" >chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
Has 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 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.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
Has gastrointestinal (GI) dysfunction that may affect drug absorption.
Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
Has clinically significant cardiovascular disease.
Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
Has history of severe bleeding disorder.
Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has received any systemic anticancer therapy for CLL/SLL.
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.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
Has active infection requiring systemic therapy.
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:

1200

Study ID:

NCT06136559

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 18 Locations for this study

See Locations Near You

Cancer Care Associates Of York ( Site 0005)
York Pennsylvania, 17403, United States More Info
Study Coordinator
Contact
717-741-8303
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
University Hospital and UW Health Clinics ( Site 0006)
Madison Wisconsin, 53792, United States More Info
Study Coordinator
Contact
608-262-9317
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa Ontario, K1H 8, Canada More Info
Study Coordinator
Contact
613-737-8899 ext. 79509
FALP-UIDO ( Site 2300)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
+56984290128
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Santiago Region M. De Santiago, 76505, Chile More Info
Study Coordinator
Contact
56992794676
Bradfordhill-Clinical Area ( Site 2310)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
56998467083
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247772541
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226778180
Sheba Medical Center-Hemato Oncology ( Site 1501)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
972526669155
Yitzhak Shamir Medical Center ( Site 1506)
Zerifin , 70300, Israel More Info
Study Coordinator
Contact
97289542443
Shimane University Hospital ( Site 1911)
Izumo Shimane, 693-0, Japan More Info
Study Coordinator
Contact
+81-853-23-2111
Yamagata University Hospital ( Site 1902)
Yamagata , 990-9, Japan More Info
Study Coordinator
Contact
+81236285840
National Cheng Kung University Hospital ( Site 1700)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
886936257940
Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
Taoyuan , 333, Taiwan More Info
Study Coordinator
Contact
+886-975366122
The Churchill Hospital ( Site 3007)
Oxford Oxfordshire, OX3 7, United Kingdom More Info
Study Coordinator
Contact
441865235886
GenesisCare - Cambridge ( Site 3001)
Newmarket Suffolk, CB8 7, United Kingdom More Info
Study Coordinator
Contact
01223216747
GenesisCare - Windsor ( Site 3002)
Windsor Windsor And Maidenhead, SL4 3, United Kingdom More Info
Study Coordinator
Contact
447989474250

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

1200

Study ID:

NCT06136559

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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