Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00727207
Status:
TERMINATED
Last Update Posted:
2012-12-17
First Post:
2008-07-31
Brief Title:
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of participations 8 of 25
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KRDI-TUM-CRAD001C2428 | None | None | None |
| EUDRACT 2007-005116-12 | None | None | None |
| EU-20855 | None | None | None |