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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487513
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment
Non-Hodgkin's Lymphoma Procedure: Procurement of Follicular B Cell Lymphoma Cells

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.

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

Primary Outcome Measures :
  1. Tissue collection for vaccine generation [ Time Frame: 2 years ]
    Collect eligible patient samples that potentially could be used to prepare autologous cell vaccines and possibly prepare autologous tumor cell injection for vaccine induced delayed-type hypersensitiviy evaluation for the companion treatment protocol. There will be no analysis performed on this protocol, the analysis will occur on a companion vaccination protocol. Patients will be consented to this protocol separately.

Biospecimen Retention:   Samples With DNA
Whole Blood Lymph node biopsy Drainage of an effusion Bone marrow biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are selected because they have Non-Hodgkin's lymphoma.

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

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 identifier (NCT number): NCT00487513

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

Responsible Party: Eric Jacobsen, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00487513     History of Changes
Other Study ID Numbers: 06-276
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Eric Jacobsen, MD, Dana-Farber Cancer Institute:
Follicular B Cell lymphoma

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