A study to compare nemtabrutinib to standard cancer treatments in people with untreated blood cancer
- Conditions
- Chronic lymphocytic leukemia/ small lymphocytic lymphomaMedDRA version: 21.1Level: LLTClassification code: 10003910Term: B-cell small lymphocytic lymphoma NOS Class: 10029104MedDRA version: 21.0Level: LLTClassification code: 10008976Term: Chronic lymphocytic leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501481-21-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 212
Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy, Previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status, 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 prior to 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) are eligible if they meet ALL of the following criteria: a) The cluster of differentiation 4 (CD4) count is >350 cells/µL at screening b) The HIV viral load is below the detectable level as per locally available testing and c) Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry, Male participants who can produce sperm are eligible to participate if participants agree to the protocol specific criteria regarding length of time to continue contraception plus either abstain from penile-vaginal intercourse or use contraception per protocol during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention, Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: is not a participant(s) of childbearing potential (POCBP) or is a POCBP and uses a contraceptive method that is highly effective with low user dependency, or is abstinent from penile-vaginal intercourse, agrees not to donate eggs to others or freeze/store during this period and agrees to the protocol specific criteria regarding length of time to continue contraception
Has active HBV/HCV infection, Participants who have not adequately recovered from major surgery or have ongoing surgical complications, Currently being treated with the following drugs: a) P-glycoprotein (P-gp) substrates with a narrow therapeutic index and b) cytochrome P450 (CYP)3A strong inducers c) CYP3A strong inhibitors, Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Has received any systemic anticancer therapy for CLL/ SLL, or an investigational agent within 5 times the half-life (or 4 weeks for monoclonal antibody treatment) or has used an investigational device within 4 weeks for any medical condition prior to study intervention administration, Has known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study, Has gastrointestinal dysfunction that may affect drug absorption, Has 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 active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening, Has acquired immunodeficiency syndrome (AIDS) defining opportunistic infection in the past 12 months prior to screening, Has QT interval corrected (QTc) prolongation or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia, Hypersensitivity to nemtabrutinib or contraindication to fludarabine plus cyclophosphamide plus rituximab (FCR) (or specified approved rituximab biosimilar)/bendamustine, or any of the excipients, Has history of severe bleeding disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method