Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169468
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2005-09-13
Brief Title:
Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Phase II Study of the Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-08
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:
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade in B-cell CD 20 lymphoma patients aged from 18 to 80 years
The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test
The other objective is to evaluate the toxicity
The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test
The other objective is to evaluate the toxicity
Detailed Description:
The association of the monoclonal antibody Rituximab to chemotherapy regimen of B-cell lymphoma is associated with an increase response rate and event free survival when compared to chemotherapy alone Coiffier et al NEJM 2002 It has been observed in almost all histological type of B-cell lymphomas No significant increase of toxicity was observed especially in the most used regimen CHOP and the association R-CHOP is a standard for most B-cell malignancies CD20 positive
However in patients with diffuse large cell lymphoma progress should be made as the complete response rate is below 75 in most situation and in low grade lymphoma although patients respond well to chemotherapy complete remission rate averaged generally 50 Marcus et al 2003 Czuczman et al 1999
There is a need to improve this association with new innovative agent Before running randomized study it is important to evaluate the like hood of getting improvement by phase 2 study testing tolerance and efficacy on a well established regimen
Bortezomib Velcade formerly PS 341 is a proteasome inhibitor which has shown promising activity in the treatment of refractory myeloma As single agent in indolent lymphomas administered twice per weeks for 2 weeks followed by one week rest period it has already showed activity in phase 2 study It is well tolerated and main toxicity was neuropathy and thrombocytopenia
Proteasome inhibitors can act through multiple mechanisms to arrest tumor growth tumor spread and angiogenesis In vitro studies have shown a synergistic effect of the association of Velcade and doxorubicin on myeloma cell lines resistant to chemotherapy
Association of Velcade to standard chemotherapy regimen is under study with the aim of improving on the results
Association of Velcade to one of the most efficient treatment of B-cell lymphoma R-CHOP might increase the response rate
However different schedules should be explored in order to better appreciate efficacy and toxicity
This randomized phase 2 study is designed to evaluate the response rate and the toxicity of two schedules of administration of Velcade in association with R-CHOP The aim of the study is to establish a well tolerated regimen giving a response rate in the limit upperlower of what is observed with conventional R-CHOP used in all the different histological subtypes of B cell lymphomas patients requiring treatment
The heterogeneity of the population will preclude any meaningful subgroup analysis
It is important to evaluate tolerability before exploring the efficacy of this new regimen in large randomized studies or in specific phases II study which will need 50 patients for each subgroup of patients
However in patients with diffuse large cell lymphoma progress should be made as the complete response rate is below 75 in most situation and in low grade lymphoma although patients respond well to chemotherapy complete remission rate averaged generally 50 Marcus et al 2003 Czuczman et al 1999
There is a need to improve this association with new innovative agent Before running randomized study it is important to evaluate the like hood of getting improvement by phase 2 study testing tolerance and efficacy on a well established regimen
Bortezomib Velcade formerly PS 341 is a proteasome inhibitor which has shown promising activity in the treatment of refractory myeloma As single agent in indolent lymphomas administered twice per weeks for 2 weeks followed by one week rest period it has already showed activity in phase 2 study It is well tolerated and main toxicity was neuropathy and thrombocytopenia
Proteasome inhibitors can act through multiple mechanisms to arrest tumor growth tumor spread and angiogenesis In vitro studies have shown a synergistic effect of the association of Velcade and doxorubicin on myeloma cell lines resistant to chemotherapy
Association of Velcade to standard chemotherapy regimen is under study with the aim of improving on the results
Association of Velcade to one of the most efficient treatment of B-cell lymphoma R-CHOP might increase the response rate
However different schedules should be explored in order to better appreciate efficacy and toxicity
This randomized phase 2 study is designed to evaluate the response rate and the toxicity of two schedules of administration of Velcade in association with R-CHOP The aim of the study is to establish a well tolerated regimen giving a response rate in the limit upperlower of what is observed with conventional R-CHOP used in all the different histological subtypes of B cell lymphomas patients requiring treatment
The heterogeneity of the population will preclude any meaningful subgroup analysis
It is important to evaluate tolerability before exploring the efficacy of this new regimen in large randomized studies or in specific phases II study which will need 50 patients for each subgroup of patients
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