Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials

This study is currently recruiting participants.
Verified February 2012 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00487513
First received: June 15, 2007
Last updated: April 23, 2013
Last verified: February 2012
  Purpose

In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting samples from people with this diagnosis. We then hope to make a vaccine from this tissue to help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank indefinitely.


Condition Intervention
Non-Hodgkin's Lymphoma
Procedure: Procurement of Follicular B Cell Lymphoma Cells

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procurement of Follicular B Cell Lymphoma Cells From Blood, Tissue or Malignant Effusion for the Purpose of Possible Use in Future Clinical Trials: A Minimal Risk Protocol

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Biospecimen Retention:   Samples With DNA

Whole Blood Lymph node biopsy Drainage of an effusion Bone marrow biopsy


Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Procurement of Follicular B Cell Lymphoma Cells
    Participants will undergo the following procedure(s) that are appropriate for collecting their tissue: Blood collection, lymph node biopsy, drainage of an effusion, or bone marrow biopsy
Detailed Description:

- The following tests and procedures will be performed: Approximately 50cc of peripheral blood will be drawn and stored in the tissue bank; patients who have follicular lymphoma cells circulating in the blood will have about 40cc's of blood drawn and stored for processing; patients undergoing a lymph node biopsy will have samples of the biopsy stored; patients having fluid drained from the abdomen or from around the lung will have some of their fluid saved to cell collection and processing; patients undergoing a bone marrow biopsy will have some of the sample stored for cell collection and processing.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants are selected because they have Non-Hodgkin's lymphoma.

Criteria

Inclusion Criteria:

  • Relapsed, refractory or de novo histologically confirmed follicular B-cell lymphoma with accessible lymph nodes, tumor mass or malignant effusion or peripheral blood
  • 35 years of age or older

Exclusion Criteria:

  • Uncontrolled active infection
  • HIV or viral Hepatitis infection
  • Other current malignancies except any in situ cancer or basal or squamous cell carcinoma of the skin
  • Autoimmune cytopenias
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487513

Contacts
Contact: Eric Jacobsen, MD 617-632-6633 edjacobsen@partners.org
Contact: Caitlin Tesmer 617-632-6840

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Eric Jacobsen, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Eric Jacobsen, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00487513     History of Changes
Other Study ID Numbers: 06-276
Study First Received: June 15, 2007
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Follicular B Cell lymphoma
vaccination

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013