WHO ICTRP trial

Study of a new drug combination for the treatment of Non Hodgkin’s Lymphoma

EUCTR2008-004177-17-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2008-004177-17-BE
Public title Study of a new drug combination for the treatment of Non Hodgkin’s Lymphoma
Scientific title A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Primary sponsor GlaxoSmithKline Research and Development Limited
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries France;Slovakia;Greece;Poland;Belgium;Austria;Germany;United Kingdom;Italy
Conditions Indolent B-cell Non-Hodgkin’s Lymphoma MedDRA version: 18.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C]…
Interventions Product Name: ofatumumab Product Code: ofatumumab Pharmaceutical Form: Solution for infusion INN or Proposed INN: Ofatumumab Current Sponsor code: GSK1841157 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal…
Registration date Feb 22, 2010
Target size 346
Secondary IDs OMB110918
Registry page clinicaltrialsregister.eu

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