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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00487513
First received: June 15, 2007
Last updated: December 14, 2015
Last verified: December 2015
  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:

Primary Outcome Measures:
  • Tissue collection for vaccine generation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487513

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

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: December 14, 2015
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, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 27, 2016