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ACTIVE NOT RECRUITING
NCT04802590
PHASE2

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Sponsor: The Lymphoma Academic Research Organisation

View on ClinicalTrials.gov

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

Interventions

DRUG

Ibrutinib 560 mg

560mg/d continuously from C1D2 to end C24

DRUG

Venetoclax 10 MG Oral Tablet [Venclexta]

20mg/d from C2D1 to C2D7

DRUG

Venetoclax 50 MG Oral Tablet [Venclexta]

50mg/d from C2D8 to C2D14

DRUG

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