Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516412
Status:
COMPLETED
Last Update Posted:
2015-09-29
First Post:
2007-08-14
Brief Title:
Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus RAD001 for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 patients with relapsed or refractory mantle cell lymphoma
PURPOSE This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma
Secondary
Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen
Investigation of immunoglobulin heavy chain variable gene somatic hypermutations Ig-V_H in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma in particular in regard to their frequency mutation distribution pattern antigen selected vs at random and the individually involved Ig-V_H families
Evaluation of a putative impact of Ig-V_H on clinical outcome
OUTLINE This is a multicenter study
Patients receive oral everolimus once daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
Primary
Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma
Secondary
Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen
Investigation of immunoglobulin heavy chain variable gene somatic hypermutations Ig-V_H in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma in particular in regard to their frequency mutation distribution pattern antigen selected vs at random and the individually involved Ig-V_H families
Evaluation of a putative impact of Ig-V_H on clinical outcome
OUTLINE This is a multicenter study
Patients receive oral everolimus once daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 1 year and then annually 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 |
|---|---|---|---|
| 2007-001108-19 | EUDRACT_NUMBER | None | None |
| EU-20749 | None | None | None |