Last updated 10 days ago
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
960 patients around the world
Available in Spain, United States, Argentina
Merck Sharp & Dohme LLC
4Research sites
960Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Follicular lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.Has radiographically measurable disease per the Lugano Response Criteria.Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
- Has received prior systemic anticancer therapy or radiotherapy for FL.Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.Has FL that has transformed into a more aggressive type of lymphoma.History or presence of clinically relevant central nervous system (CNS) diseases.Has history of serious cardiovascular and cerebrovascular diseases.Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.Has known active CNS lymphoma or involvement.Has an active autoimmune disease that has required systemic treatment in the past 2 years.Has active infection requiring systemic therapy.Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.Has not adequately recovered from major surgery or has ongoing surgical complications.
Sites
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Alemán
Recruiting
Sanatorio Nuestra Señora del Rosario
Recruiting
Hospital Privado de Córdoba
Recruiting
StudyMK-1045-007
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Follicular lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07634471
