Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
- 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.
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.
Catherine J. Wu, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|