Status:
COMPLETED
Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
T-cell Lymphoma
B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
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 fact...
Detailed Description
Background: * The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years. * Blood obtained by apheresis or blood dra...
Eligibility Criteria
- INCLUSION CRITERIA:
Participants must meet at least one of these criteria:
Have suspected or known disorder of the immune system or cancer
Be a known or potential carrier of autoimmune disorder or immunodeficiency disease. Specific disorders may include but are not limited to:
- X-linked (severe combined immunodeficiency)
- Autosomal recessive SCID
- X-linked CD40 ligand deficiency
- Common variable immunodeficiency
- Ataxia-telangiectasia
- Wiskott Aldrich syndrome
- DiGeorge syndrome
- Infection with HTLV-1
Age greater than or equal to 18 years.
Participant must be able to understand and sign informed consent.
Participants who will undergo apheresis must have hematocrit greater than 28%, and platelet count greater than 50,000.
Subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician.
Weight greater than 25 kg is necessary for apheresis.
EXCLUSION CRITERIA:
Overall Exclusion Criteria:
Pregnant women will not be eligible for any aspect of this protocol.
Exclusion Criteria for Apheresis Alone:
Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:
- Congestive Heart Failure
- History of angina
- Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.)
- Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
- History of a coagulation protein disorder.
Pediatric patients (less than 18 years) will not undergo apheresis.
Key Trial Info
Start Date :
June 7 1997
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
902 Patients enrolled
Trial Details
Trial ID
NCT00001582
Start Date
June 7 1997
End Date
March 17 2023
Last Update
March 21 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892