Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

NCT ID: NCT00428233

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leukemia Cell Harvest

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

Group Type: NO_INTERVENTION

Leukemia cell harvest

Intervention Type: PROCEDURE

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

Interventions

Leukemia cell harvest

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Catherine Wu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine J. Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

06-200

Identifier Type: -

Identifier Source: org_study_id