Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy|
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity and feasibility [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
- Comparison of duration of remission after first- vs second-line chemotherapy [ Designated as safety issue: No ]
- Rate of objective remission [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.
- Determine the toxicity and feasibility of treatment with this drug.
- Determine the efficacy of this drug in these patients.
- Compare the duration of remission after first- vs second-line chemotherapy.
- Determine the rate of objective remission.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727207
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Principal Investigator:||Ulrich Keller, MD||Technische Universität München|