Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Procedure: Leukemia cell harvest

Study type: Interventional

Funder types: Other

Identifiers

NCT00428233

06-200

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Leukemia Cell Harvest

No Intervention group

Description:

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

Treatment:

Procedure: Leukemia cell harvest