NCT01520922 - Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

February 28, 2013

Study Completion Date

November 30, 2015

Conditions

Chronic Lymphocytic Leukemia (CLL)Leukaemia, Lymphocytic, Chronic

Interventions

BIOLOGICAL

Ofatumumab

Ofatumumab (ARZERRA™) is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells.

DRUG

Bendamustine

Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group.

Trial Locations (33)

1200

Novartis Investigative Site, Brussels

3000

Novartis Investigative Site, Leuven

9000

Novartis Investigative Site, Ghent

10126

Novartis Investigative Site, Turin

20122

Novartis Investigative Site, Milan

28006

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

28222

Novartis Investigative Site, Majadahonda (Madrid)

33705

Novartis Investigative Site, St. Petersburg

33916

Novartis Investigative Site, Fort Myers

37203

Novartis Investigative Site, Nashville

41124

Novartis Investigative Site, Modena

80045

Novartis Investigative Site, Aurora

84403

Novartis Investigative Site, Ogden

85719

Novartis Investigative Site, Tuscon

115478

Novartis Investigative Site, Moscow

191024

Novartis Investigative Site, St'Petersburg

420029

Novartis Investigative Site, Kazan'

630087

Novartis Investigative Site, Novosibirsk

625 00

Novartis Investigative Site, Brno

Unknown

Novartis Investigative Site, Hradec Králové

775 20

Novartis Investigative Site, Olomouc

128 08

Novartis Investigative Site, Prague

11 527

Novartis Investigative Site, Athens

564 29

Novartis Investigative Site, Thessaloniki

00161

Novartis Investigative Site, Rome

00168

Novartis Investigative Site, Rome

41-500

Novartis Investigative Site, Chorzów

76-200

Novartis Investigative Site, Słupsk

50-367

Novartis Investigative Site, Wroclaw

197 089

Novartis Investigative Site, Saint Petersburg

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona