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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00487513
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 115.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated 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: Jun 1, 2007
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Outcome Measures

Primary Outcome Measures

1. Tissue collection for vaccine generation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Jacobsen, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00487513
• Other Study ID Numbers: 06-276
• First Posted: Jun 18, 2007
• Last Update Posted: Mar 9, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Eric Jacobsen, MD, Principal Investigator, Dana-Farber Cancer Institute: Follicular B Cell lymphoma; vaccination
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell

Study Results

No Results Posted as of Mar 9, 2017