Spots Global Cancer Trial Database for Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
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Trial Identification
Brief Title: Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
Official Title: Phase I/II Trial of Dexamethasone, Ofatumumab and Bendamustine [Treanda] (DOT) as First-line Treatment of Mantle-cell Lymphoma (MCL) in the Elderly
Study ID: NCT01221103
Conditions
Study Description
Brief Summary: The rationale for this study design is based on the fact that the maximum tolerated dose (MTD) of single-agent ofatumumab and bendamustine have been previously determined. The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive experimental data on the use of other monoclonal antibodies in combination chemotherapy in lymphoma patients. The starting dose of the 2 main component drugs is the MTD of each drug as single agent.
Detailed Description:
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fondazione IRCCS Istituto Nazionale Tumori, Milano, , Italy
Ospedali Bianchi - Melacrino - Morelli, Reggio Di Calabria, , Italy
Contact Details
Name: Alessandro M. Gianni, MD
Affiliation: Istituto Nazionale Tumori Milano
Role: STUDY_CHAIR
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