NEMTABRUTINIB for Chronic lymphocytic leukemia | Small lymphocytic lymphoma

Inclusion criteria

• {"criterion_text":"- Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to have a need to initiate therapy."}
• {"criterion_text":"- Has at least 1 marker of disease burden."}
• {"criterion_text":"- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization."}
• {"criterion_text":"- Has the ability to swallow and retain oral medication."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening."}
• {"criterion_text":"- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria."}

Exclusion criteria

• {"criterion_text":"- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids."}
• {"criterion_text":"- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed."}
• {"criterion_text":"- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed."}
• {"criterion_text":"- Has active infection requiring systemic therapy."}
• {"criterion_text":"- Participants who have not adequately recovered from major surgery or have ongoing surgical complications."}
• {"criterion_text":"- Has gastrointestinal (GI) dysfunction that may affect drug absorption."}
• {"criterion_text":"- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL."}
• {"criterion_text":"- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening."}
• {"criterion_text":"- Has QT interval corrected (QTc) prolongation or other significant electrocardiogram (ECG) abnormalities."}
• {"criterion_text":"- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients."}
• {"criterion_text":"- Has history of severe bleeding disorder."}
• {"criterion_text":"- Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years."}
• {"criterion_text":"- Has received any systemic anticancer therapy for CLL/SLL."}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Assessed per iwCLL Criteria 2018 by Blinded Independent Central Review (BICR)."}
• {"endpoint_text":"- Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR","definition_or_measurement_approach":"Assessed per iwCLL Criteria 2018 by Blinded Independent Central Review (BICR)."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR","definition_or_measurement_approach":"Assessed per iwCLL Criteria 2018 by Blinded Independent Central Review (BICR)."}
• {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}

Methods

• Reify Health: recruitment activities (listed under third parties with role 'recruitment activities').

Belgium

Latest Decision Or Authorization Date

15-01-2024

Czechia

Latest Decision Or Authorization Date

19-01-2024

Denmark

Latest Decision Or Authorization Date

22-01-2024

Germany

Latest Decision Or Authorization Date

22-12-2023

Greece

Latest Decision Or Authorization Date

04-12-2023

Spain

Earliest CTIS Part Ii Submission Date

11-12-2023

Latest Decision Or Authorization Date

22-01-2024

Processing Time Days

42

Number Of Sites

8

Number Of Participants

50

Sweden

Latest Decision Or Authorization Date

15-01-2024

Norway

Latest Decision Or Authorization Date

19-01-2024

Poland

Latest Decision Or Authorization Date

15-01-2024

Portugal

Latest Decision Or Authorization Date

05-01-2024

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Signant Health LLC

Responsibilities

sponsorDuties code 3

Name

Reify Health

Responsibilities

recruitment activities

Name

IQVIA Limited

Responsibilities

sponsorDuties code 4

Name

Bioclinica Inc.

Responsibilities

Central Imaging

Name

Parexel International Corp.

Responsibilities

Medical information (Physician consulting)

Name

Perceptive Eclinical Limited

Responsibilities

EUB Call center and medical escalation service

Third parties

• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Reify Health","duties_or_roles":"recruitment activities","organisation_type":"Industry"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician consulting)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}