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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lymphoma
- Sponsor
- Technical University of Munich
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free survival
Secondary Outcomes
- Toxicity and feasibility
- Efficacy
- Comparison of duration of remission after first- vs second-line chemotherapy
- Rate of objective remission