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Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
Sponsor: The Lymphoma Academic Research Organisation
Summary
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and \< 80 years of age). Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years. The primary aim is to assess MRD status at 6 months in both arms.
Official title: A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2022-01-24
Completion Date
2031-09-30
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Ibrutinib 560 mg
560mg/d continuously from C1D2 to end C24
Venetoclax 10 MG Oral Tablet [Venclexta]
20mg/d from C2D1 to C2D7
Venetoclax 50 MG Oral Tablet [Venclexta]
50mg/d from C2D8 to C2D14
Venetoclax 100 MG Oral Tablet [Venclexta]
100mg/d from C2D15 to C2D21 200mg/d from C2D22 to C2D28 400mg/d from C3D1 to end C24
Locations (45)
A.Z. Sint Jan AV
Bruges, Belgium
Universite Libre de Bruxelles - Hopital ERASME
Brussels, Belgium
Hopital Jolimont
Haine-Saint-Paul, Belgium
CHU de Liege
Liège, Belgium
Universite Catholique de Louvain Mont Godinne
Yvoir, Belgium
CHU d'Angers
Angers, France
CH d'Avignon - Hopital Henri Duffaut
Avignon, France
CH de la Côte Basque
Bayonne, France
CHU Jean Minioz
Besançon, France
Chu de Brest - Hopital de La Cavale Blanche
Brest, France
Institut d'Hématologie de Basse Normandie
Caen, France
Chu Estaing
Clermont-Ferrand, France
CH Henri Mondor
Créteil, France
CHU de DIJON
Dijon, France
CHD de Vendée
La Roche-sur-Yon, France
CHU de Grenoble
La Tronche, France
CHRU de Lille
Lille, France
Hopital DUPUYTREN
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Hopital St-Louis
Paris, France
Hopital NECKER
Paris, France
Chu de Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Hopital de la Milétrie
Poitiers, France
Ch Annecy Gennevois
Pringy, France
CH de Cornouaille
Quimper, France
CHU de REIMS
Reims, France
CHU Pontchaillou
Rennes, France
Centre Henri BECQUEREL
Rouen, France
Hopital René Huguenin
Saint-Cloud, France
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, France
Institut de Cancérologie Strasbourg Europe
Strasbourg, France
IUCT Oncopole
Toulouse, France
CHU Bretonneau
Tours, France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, France
CH de Bretagne Atlantique - Hopital CHUBERT
Vannes, France
Institut Gustave ROUSSY
Villejuif, France
The Christie NHS Foundation Trust
Manchester, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Royal Cornwall Hospital Trust
Truro, United Kingdom