Clinical Trials List
Protocol NumberMK-1026-008
NCT Number(ClinicalTrials.gov Identfier)NCT05624554
Active
2022-12-01 - 2031-12-31
Phase III
Recruiting3
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
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- - - Division of General Internal Medicine
- CHENG-HONG TSAI Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- Chien-Chin Lin Division of Others -
- Wen-Chien Chou Division of Hematology & Oncology
- Huai-Hsuan Huang Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- 田豐銘 Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Lymphocytic Leukemia、Small Lymphocytic Lymphoma
Objectives
To compare nemtabrutinib with chemoimmunotherapy of the trial sponsor's choice (FCR or BR) in subjects with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) without TP53 aberrations (i.e., 17p deletion and/or TP53 mutation) from randomization to first documented disease progression or death from any cause (PFS).
Test Drug
1026FludarabineCyclophosphamideMK-1026
Active Ingredient
Nemtabrutinib (MK-1026, formerly known as ARQ 531)
Fludarabine
Cyclophosphamide
Nemtabrutinib (MK-1026, formerly known as ARQ 531)
Fludarabine
Cyclophosphamide
Nemtabrutinib (MK-1026, formerly known as ARQ 531)
Dosage Form
Tablet
Vial
Vial
Tablet
Vial
Vial
Tablet
Dosage
5 mg
25mg/mL
1g/VL
20mg
25mg/mL
1g/VL
20mg
Endpoints
PFS assessed by BICR according to the 2018 iwCLL criteria
PFS: time from randomization to first documented disease progression or death from any cause, whichever occurs first
PFS: time from randomization to first documented disease progression or death from any cause, whichever occurs first
Inclution Criteria
Inclusion Criteria:
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
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
Exclusion Criteria
Exclusion Criteria:
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
History of severe bleeding disorders
Not adequately recovered from major surgery or has ongoing surgical complications
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy
History of severe bleeding disorders
Not adequately recovered from major surgery or has ongoing surgical complications
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
300 participants
