A study to find out whether Odronextamab is safe and well tolerated and how effective it is compared to Rituximab in combination with different types of chemotherapy in participants with follicular lymphoma
Zusammenfassung der Studie
The study investigates the drug Odronextamab, referred to as the investigational product. The study focuses on patients with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma, NHL). The study is divided into Part 1 and Part 2. The aim of Part 1 of the study is to determine how safe and well tolerated the investigational product is. The aim of Part 2 of the study is to investigate the effect of Odronextamab compared to Rituximab and chemotherapy (the current standard treatment for non-Hodgkin lymphoma). Several research questions are explored in the study, including: • What side effects can the investigational product cause? • How much of the investigational product is present in the blood at different times? • Does the body produce antibodies against the investigational product (which could make the drug less effective or lead to side effects)? • The effects of the investigational product on the quality of life and daily functioning of the patients.
(BASEC)
Untersuchte Intervention
Odronextamab is a monoclonal antibody described as bispecific because it can individually recognize and bind to 2 cell proteins (CD20 and CD3). Proteins are part of every cell in the body, working like small machines to ensure the function of the cell. CD20 is a protein found on the surface of both normal B cells and B cells that form certain cancers, such as follicular lymphoma. CD3 is a protein found on the surface of T cells. T cells and normal B cells are types of white blood cells in the body and are part of the immune system that fights infections. Odronextamab is intended to help T cells find and kill B cells, including cancer cells in follicular lymphoma.
(BASEC)
Untersuchte Krankheit(en)
Participants must be at least 18 years old and have untreated follicular lymphoma.
(BASEC)
– Participants must be at least 18 years old – have follicular lymphoma – Participants have not received prior treatment for follicular lymphoma (BASEC)
Ausschlusskriterien
– Participants with follicular lymphoma that has occurred in the brain or has spread to the brain (known as leptomeningeal involvement) or with certain cancers such as central nervous system lymphoma, high-grade follicular lymphoma (also referred to as type 3b) or with diffuse large B-cell lymphoma – Participants with uncontrolled hepatitis B, uncontrolled hepatitis C, or uncontrolled HIV infections (human immunodeficiency virus). If your blood tests positive for cytomegalovirus (CMV), you must receive treatment for that and show a negative test result on two occasions at least one week apart before you can be included in the study. – Pre-existing conditions of the brain and spinal cord, as described in the study protocol (BASEC)
Studienstandort
Basel, Bern, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Baden
(BASEC)
Sponsor
ICON Clinical Research GmbH Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Clinical Trials Administrator
+1 844-734-6643
clinicaltrials@clutterregeneron.comRegeneron Pharmaceuticals, Inc.
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.11.2023
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Eine offene, randomisierte Phase-III-Studie zum Vergleich der Wirksamkeit und Sicherheit von Odronextamab (REGN1979), einem bispezifischen Anti-CD20 x Anti-CD3-Antikörper, gegenüber der Wahl des Prüfarztes bei zuvor unbehandelten Teilnehmern mit follikulärem Lymphom (OLYMPIA-1) (BASEC)
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Einschluss des ersten Teilnehmers
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Ergebnisse der Studie
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