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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Jacobsen, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00487513
First received: June 15, 2007
Last updated: March 8, 2017
Last verified: March 2017
June 15, 2007
March 8, 2017
June 2007
January 2017   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00487513 on ClinicalTrials.gov Archive Site
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Procurement of Follicular B Cell Lymphoma Cells for the Purpose of Possible Use in Future Clinical Trials
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
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.
- 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Whole Blood Lymph node biopsy Drainage of an effusion Bone marrow biopsy
Non-Probability Sample
Participants are selected because they have Non-Hodgkin's lymphoma.
Non-Hodgkin's Lymphoma
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2017
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00487513
06-276
No
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Eric Jacobsen, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
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Principal Investigator: Eric Jacobsen, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP