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Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

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ClinicalTrials.gov Identifier: NCT00428233
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Procedure: Leukemia cell harvest Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Actual Study Start Date : November 2006
Primary Completion Date : June 2014
Study Completion Date : June 2014


Arms and Interventions

Arm Intervention/treatment
No Intervention: 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
Procedure: Leukemia cell harvest
Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node


Outcome Measures

Primary Outcome Measures :
  1. To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428233


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Catherine J. Wu, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Catherine Wu, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00428233     History of Changes
Other Study ID Numbers: 06-200
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Catherine Wu, MD, Dana-Farber Cancer Institute:
CLL
vaccine

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Vaccines
Immunologic Factors
Physiological Effects of Drugs