Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Procedure: Leukemia cell harvest


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Leukemia Cell Harvest<br>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<br>* Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, vaccine