Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428233
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2007-01-25
Brief Title:
Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Status:
COMPLETED
Status Verified Date:
2020-04
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 research study is to collect freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia CLL that is not in clinical remission This study is a companion study to DFHCC clinical trial 06-196 in which the participants own CLL cells may form part of a vaccine treatment for their leukemia
Detailed Description:
It is important to understand that even if the participant consents to allow us to save their leukemia cells we cannot guarantee that they will be able to receive a vaccine First we may not be able to make enough vaccine from the collected cells Second they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health Third an appropriate vaccine trial may not be available in the future
In order to make the vaccine leukemia cells will be collected by one or more of the following methods drawing blood during one of two visits to the clinic leukapheresis bone marrow aspiration or surgery to remove a lymph node
The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected
In order to make the vaccine leukemia cells will be collected by one or more of the following methods drawing blood during one of two visits to the clinic leukapheresis bone marrow aspiration or surgery to remove a lymph node
The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected
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