Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection
Sponsor study identifier
Secondary identifiers
observational
902
1 country
1
Study Start
June 7, 1997
Actual (reported)Primary Completion
March 17, 2023
Actual (reported)Study Completion
March 17, 2023
Actual (reported)This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity....
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 17, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 1997
Actual (reported)November 3, 1999
Actual (reported)November 4, 1999
Actual (reported)March 17, 2023
Actual (reported)March 17, 2023
Actual (reported)Create Biobank
No statistical endpoints are identified for this study; the purpose of the study is to acquire information regarding various immunodeficiency syndromes, HTLV-1 infection and malignancies. The data collected will not be combined for a summary report of the entire study; however, reports for specific disease entities may be published.
Ongoing
Suspected or known disorder of the immune system or cancer; or, known or potential carrier of autoimmune disorder or immunodeficiency disease.
Primary clinical patients/population with a suspected or known disorder of the immune system or cancer per the eligibility criteria.@@@
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Whole blood, serum, tissue, bone marrow aspirate and biopsy
Kevin C Conlon, M.D.
National Cancer Institute (NCI)
902 participants (actual enrollment reported by the registry).
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
June 7, 1997
Actual (reported)A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
Contact the study team to confirm eligibility.
Primary Completion
March 17, 2023
Actual (reported)Study Completion
March 17, 2023
Actual (reported)Last Updated
March 21, 2023
Record last verified: 2023-03
.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. @@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Source: ClinicalTrials.gov.
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