Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151281
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2005-09-06
Brief Title:
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-06
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:
Primary Objective
Evaluate the clinical activity of the RT-PEPC combination regimen rituximab thalidomide and prednisone etoposide procarbazine cyclophosphamide in patients with relapsed mantle cell lymphoma Specifically response rate RR and time to disease progression TTP will be assessed
Secondary Objectives
1 Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma
2 Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy
3 Assess the quality of life of patients receiving RT-PEPC treatment
Evaluate the clinical activity of the RT-PEPC combination regimen rituximab thalidomide and prednisone etoposide procarbazine cyclophosphamide in patients with relapsed mantle cell lymphoma Specifically response rate RR and time to disease progression TTP will be assessed
Secondary Objectives
1 Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma
2 Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy
3 Assess the quality of life of patients receiving RT-PEPC treatment
Detailed Description:
None
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