NCT00727207

Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	everolimus

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-05-01
• Completion: 2014-09-01
• First posted: 2008-08-01
• Last updated: 2012-12-17

Locations

1 site across 1 country: Germany