Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440583
Status:
COMPLETED
Last Update Posted:
2015-01-30
First Post:
2007-02-26
Brief Title:
The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Yt90 Zevalin Combination Chemotherapy in Treating Patients With Stage IIStage IIIor Stage IV Diffuse Large B-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-01
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 purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy
Detailed Description:
Diffuse large B-cell lymphomas DLBCL are the most common lymphoid neoplasm and account for 30 to 40 of adult non-Hodgkin lymphomas NHL DLCBL is a potentially curable disease The ultimate goals of introducing new modality treatments such as monoclonal antibody Ab-targeted therapy are to increase complete remission CR rate and prolong event-free survival and overall survivalIn phase II trials it was shown that in DLBL the addition of rituximab to CHOP was feasible with an increase in ORR including CR and an increase in the OS and PFS in patients with DLBL2 The benefit of R-CHOP was consistent across all subgroups of patients tested including good and poor risks according to IPI and independent of younger than 70 years and older than 70 years of age
Recently new radiolabeled monoclonal antibodies have been established in the therapy of malignant lymphoma which can induce high remission rates Radiolabeled antibodies are particularly effective as lymphoma cells are highly sensitive to radiation In addition the local emission of radiolabeled antibodies is able to destroy cells in close proximity to the bound antibody bystander effect therefore circumventing the problem of limited perfusion of bulky or poorly vascularized tumorsIbritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90 producing Yt90-ibritumomab tiuxetan Yt90-Zevalin To optimize biodistribution Rituximab is given prior to the radiolabeled antibody Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab ORR in the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group 80 vs 56 according to International Workshop Response criteria or 73 vs 47 according to protocol-defined evaluation of response
Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkins lymphoma it is worthwhile to study the consolidation therapy with Yt90-ibritumomab tiuxetan Yt90-Zevalin in patients who achieved at least unconfirmed partial remission after 6 cycles of CHOP therapy
Recently new radiolabeled monoclonal antibodies have been established in the therapy of malignant lymphoma which can induce high remission rates Radiolabeled antibodies are particularly effective as lymphoma cells are highly sensitive to radiation In addition the local emission of radiolabeled antibodies is able to destroy cells in close proximity to the bound antibody bystander effect therefore circumventing the problem of limited perfusion of bulky or poorly vascularized tumorsIbritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90 producing Yt90-ibritumomab tiuxetan Yt90-Zevalin To optimize biodistribution Rituximab is given prior to the radiolabeled antibody Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab ORR in the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group 80 vs 56 according to International Workshop Response criteria or 73 vs 47 according to protocol-defined evaluation of response
Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkins lymphoma it is worthwhile to study the consolidation therapy with Yt90-ibritumomab tiuxetan Yt90-Zevalin in patients who achieved at least unconfirmed partial remission after 6 cycles of CHOP therapy
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