Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
- Conditions
- Lymphoma
- Registration Number
- NCT00727207
- Lead Sponsor
- Technical University of Munich
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Toxicity and feasibility Efficacy Comparison of duration of remission after first- vs second-line chemotherapy Rate of objective remission
Trial Locations
- Locations (1)
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany