Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
NCT00786851 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2016-08-17
Summary
This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).
Conditions
Interventions
- DRUG
-
Lenalidomide and Dexametasone
Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).
Sponsors & Collaborators
-
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
collaborator OTHER -
Fondazione Italiana Linfomi - ETS
lead OTHER
Principal Investigators
-
Francesco Zaja, MD · Ospedale S. Maria della Misericordia, Udine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2010-07-31
- Completion
- 2011-08-31
Countries
- Italy
Study Locations
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