Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
This study is currently recruiting participants.
Verified January 2013 by Dana-Farber Cancer Institute
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Catherine Wu, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00428233
First received: January 25, 2007
Last updated: February 6, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Procedure: Leukemia cell harvest |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428233
Contacts
| Contact: Catherine J. Wu, MD | 617-632-5943 | catherine_wu@dfci.harvard.edu |
| Contact: Mildred Pasek, RN | mpasek@partners.org |
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| 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
No publications provided
| Responsible Party: | Catherine Wu, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00428233 History of Changes |
| Other Study ID Numbers: | 06-200 |
| Study First Received: | January 25, 2007 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
CLL vaccine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013