Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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of the doses for the combination is based on the investigators unpublished clinical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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Southern Europe New Drug Organization
Collaborator:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano