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Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Phase 1
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

Thank you

Trial Information

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.

Inclusion Criteria:

- Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow,
defined as > 30% involvement of bone marrow intratrabecular space, or peripheral
blood lymphocytosis > 5000/microliter, or surgically accessible lymph nodes of
greater than or equal to 2cm.

- ECOG performance status 0-2

- 18 years of age or older

Exclusion Criteria:

- Uncontrolled infection

- Leukemia with active CNS involvement

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Catherine J. Wu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

November 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • vaccine
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Dana-Farber Cancer Institute Boston, Massachusetts  02115