Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/2/2019 |
| Start Date: | November 2006 |
| End Date: | June 2014 |
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.
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.
- 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.
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
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