Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00428233|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Procedure: Leukemia cell harvest||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation|
|Actual Study Start Date :||November 2006|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428233
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Catherine J. Wu, MD||Dana-Farber Cancer Institute|