Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01848132
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2013-05-03
Brief Title:
EfficacySafety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI
Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Organization:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study Overview
Official Title:
Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI
Status:
COMPLETED
Status Verified Date:
2018-09
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:
Diffuse large B cell lymphoma DLBCL is the most common non-Hodgkins lymphoma accounting for between 30 and 50 of the patients Although it is considered a curable disease still at least 40 of the patients will fail first line chemotherapy The International Prognostic Index IPI score and the age adjusted IPI aIPI has been used since they were published to identify patients with different outcome
There is not standard therapy for young patients with DLBCL and unfavourable IPI score The survival of these patients remains poor with EFS around 40
The combination of RCHOP with new drugs is an attractive approach to treat these patients
The goal is to evaluate the proportion of patients with Event-Free Survival EFS after 2 years with a diagnosis of DLBCL with an aIPI 1 or an aIPI 1 with increased levels of beta-2-microglobulin above the Upper Limits of Normal
There is not standard therapy for young patients with DLBCL and unfavourable IPI score The survival of these patients remains poor with EFS around 40
The combination of RCHOP with new drugs is an attractive approach to treat these patients
The goal is to evaluate the proportion of patients with Event-Free Survival EFS after 2 years with a diagnosis of DLBCL with an aIPI 1 or an aIPI 1 with increased levels of beta-2-microglobulin above the Upper Limits of Normal
Detailed Description:
Diffuse large B cell lymphoma DLBCL is the most common non-Hodgkins lymphoma accounting for between 30 and 50 of the patients Although it is considered a curable disease still at least 40 of the patients will fail first line chemotherapy The International Prognostic Index IPI score and the age adjusted IPI aIPI has been used since they were published to identify patients with different outcome
CHOP chemotherapy administered every 21 days has been for years the standard therapy for advanced DLBCL achieving a long term overall survival OS of about 40 Many studies show that the addition of the monoclonal antibody Rituximab improves the patients survival achieving higher rates of event-free survival in elderly patients with bothfavourable and unfavourable IPI score R-CHOP also improved survival in young patients with favourable IPI score
There is not standard therapy for young patients with DLBCL and unfavourable IPI score The survival of these patients remains poor with EFS around 40
The combination of RCHOP with new drugs is an attractive approach to treat these patients
The investigators propose a phase II randomized clinical trial for young patients with unfavourable IPI score DLBCL using 6 cycles of the combination of subcutaneous Bortezomib with R-CAP RCHOP without vincristine to avoid neuropathy comparing with the standard immunochemotherapy regimen R- CHOP every 21 days
The goal is to evaluate the proportion of patients with Event-Free Survival EFS after 2 years with a diagnosis of DLBCL with aIPI 1 or aIPI 1 with increased levels of beta-2-microglobulin above the Upper Limits of Normal
CHOP chemotherapy administered every 21 days has been for years the standard therapy for advanced DLBCL achieving a long term overall survival OS of about 40 Many studies show that the addition of the monoclonal antibody Rituximab improves the patients survival achieving higher rates of event-free survival in elderly patients with bothfavourable and unfavourable IPI score R-CHOP also improved survival in young patients with favourable IPI score
There is not standard therapy for young patients with DLBCL and unfavourable IPI score The survival of these patients remains poor with EFS around 40
The combination of RCHOP with new drugs is an attractive approach to treat these patients
The investigators propose a phase II randomized clinical trial for young patients with unfavourable IPI score DLBCL using 6 cycles of the combination of subcutaneous Bortezomib with R-CAP RCHOP without vincristine to avoid neuropathy comparing with the standard immunochemotherapy regimen R- CHOP every 21 days
The goal is to evaluate the proportion of patients with Event-Free Survival EFS after 2 years with a diagnosis of DLBCL with aIPI 1 or aIPI 1 with increased levels of beta-2-microglobulin above the Upper Limits of Normal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2012-005138-12 | EUDRACT_NUMBER | None | None |