Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386321
Status:
TERMINATED
Last Update Posted:
2010-11-18
First Post:
2006-10-10
Brief Title:
Yt90 Zevalin and Combination Chemotherapy Z-CHOPin Treating Patients With Stage II Stage III or Stage IV Diffuse Large B-cell Lymphoma
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
Yt90Zevalin Plus CHOP Z-CHOP
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Participants are no longer being examined or treated
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 whether the treatment of Yt90 Zevalin in combination with CHOP cyclophosphamide doxorubicin vincristine and prednisoloneare effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma
Detailed Description:
Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkins lymphoma The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan Zevalin include the induction of apoptosis and cell-cycle redistribution
The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy
Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy with only minimal alopecia mucositis nausea or vomiting and a lower incidence of infections
Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used
The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy
Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy with only minimal alopecia mucositis nausea or vomiting and a lower incidence of infections
Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used
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