Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
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 DF/HCC clinical trial 06-196 in which the participants own CLL cells may form part of a vaccine treatment for their leukemia.
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation|
- To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
No Intervention: Leukemia Cell Harvest
Procedure/Surgery: Leukemia cell harvest Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node
Procedure: Leukemia cell harvest
Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428233
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Catherine J. Wu, MD||Dana-Farber Cancer Institute|