drugset / Trial / NCT01221103
Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
Phase 1/2
Unknown
50 enrolled
Southern Europe New Drug Organization
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · collab
NaSingle-groupOpen-labelTreatment
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 The choice of the doses for the combination is based on the investigators unpublished clinical experience, as well as inferred from extensive experimental data on the use of other monoclonal antibodies in combination chemotherapy in lymphoma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.
Timeline
- Start
- 2010-04
- Primary completion
- 2012-04
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |