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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Allocation: Non-Randomized, Primary Purpose: Treatment
Progression-free survival
No
Ulrich Keller, MD
Principal Investigator
Technische Universität München
Germany: Federal Institute for Drugs and Medical Devices
CDR0000597004
NCT00727207
May 2008
September 2014
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