Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374699
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2006-09-07
Brief Title:
Bortezomib and CHOP in Patients With Advanced Stage Aggressive T Cell or Natural Killer NKT Cell Lymphomas
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Phase III Study of Bortezomib CHOP in Patients With Advanced Stage Aggressive T Cell or NKT Cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Peripheral T-cell lymphomas PTCLs are neoplasias from post-thymic T-cells at different stages of differentiation and are a heterogeneous group of malignancies which present with different morphological patterns phenotypes and clinical presentations
These tumours have a striking epidemiological distribution with a lower incidence in Western countries than in Asia In Korea PTCLs including T- or natural killer NK-cell lymphomas constitute approximately 25 to 35 of all non-Hodgkins lymphomas This incidence is quite similar to that of other Eastern Asian countries including Japan Hong Kong and China
Recent studies suggest that the T-cell phenotype is an independent significant prognostic factor with PTCLs having one of the lowest overall survival and failure-free survival rates Based on the investigators experience the overall complete remission rate was 612 95 confidence interval CI 485-728 and the 5-year probability of failure-free survival was 335 Median survival of all patients was 45 months range 0-64 months and the 5-year probability of survival was 362 Rassidakis et al reported that expression of pro-apoptotic proteins BAX and BCL-XS may explain the poor response of many types of PTCL to standard chemotherapy
To overcome such poor outcome the optimal therapy for PTCLs remains to be defined However because of the rarity of the disease in Western countries only a few trials have been reported
Bortezomib Velcade is a modified dipeptidyl boronic acid and a reversible inhibitor of the chymotrypsin-like activity of the 26S proteosome Bortezomib may induce tumor cell apoptosis or decreased bcl-2 associated drug resistance Through phase II studies single agent bortezomib in patients with relapsed indolent and mantle cell lymphomas showed its activity And also preliminary data indicate that bortezomib can be safely administered in combination with dose adjusted etoposide prednisolone vincristine cyclophosphamide and doxorubicin EPOCH chemotherapy Therefore it can be possible to improve the poor outcome of patients with PTCLs by a combination of cyclophosphamide doxorubicin vincristine prednisolone CHOP with bortezomib as a first-line therapy
Primary Hypothesis Based on the clinical trials and experimental data bortezomib can overcome pro-apoptotic proteins BAX and BCL-XS induced drug resistance
These tumours have a striking epidemiological distribution with a lower incidence in Western countries than in Asia In Korea PTCLs including T- or natural killer NK-cell lymphomas constitute approximately 25 to 35 of all non-Hodgkins lymphomas This incidence is quite similar to that of other Eastern Asian countries including Japan Hong Kong and China
Recent studies suggest that the T-cell phenotype is an independent significant prognostic factor with PTCLs having one of the lowest overall survival and failure-free survival rates Based on the investigators experience the overall complete remission rate was 612 95 confidence interval CI 485-728 and the 5-year probability of failure-free survival was 335 Median survival of all patients was 45 months range 0-64 months and the 5-year probability of survival was 362 Rassidakis et al reported that expression of pro-apoptotic proteins BAX and BCL-XS may explain the poor response of many types of PTCL to standard chemotherapy
To overcome such poor outcome the optimal therapy for PTCLs remains to be defined However because of the rarity of the disease in Western countries only a few trials have been reported
Bortezomib Velcade is a modified dipeptidyl boronic acid and a reversible inhibitor of the chymotrypsin-like activity of the 26S proteosome Bortezomib may induce tumor cell apoptosis or decreased bcl-2 associated drug resistance Through phase II studies single agent bortezomib in patients with relapsed indolent and mantle cell lymphomas showed its activity And also preliminary data indicate that bortezomib can be safely administered in combination with dose adjusted etoposide prednisolone vincristine cyclophosphamide and doxorubicin EPOCH chemotherapy Therefore it can be possible to improve the poor outcome of patients with PTCLs by a combination of cyclophosphamide doxorubicin vincristine prednisolone CHOP with bortezomib as a first-line therapy
Primary Hypothesis Based on the clinical trials and experimental data bortezomib can overcome pro-apoptotic proteins BAX and BCL-XS induced drug resistance
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