Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00727207|
Recruitment Status : Terminated (Lack of participations (8 of 25))
First Posted : August 1, 2008
Last Update Posted : December 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: everolimus||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||September 2014|
- Progression-free survival
- Toxicity and feasibility
- Comparison of duration of remission after first- vs second-line chemotherapy
- Rate of objective remission
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727207
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Principal Investigator:||Ulrich Keller, MD||Technische Universität München|