Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428233
• Other study ID #: 06-200
• Status: Completed
• Phase: Phase 1
• Start date: November 2006
• Est. completion date: June 2014

Study information

• Verified date: April 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Leukemia cell harvest
Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.		2 years