Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00428233

Enrollment

Registered

2007-01-29

Start date

2006-11-30

Completion date

2014-06-30

Last updated

2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, vaccine

Brief 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.

Detailed 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.

Interventions

PROCEDURELeukemia cell harvest

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026