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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|