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:

  1. Congestive Heart Failure
  2. History of angina
  3. 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.)
  4. Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
  5. 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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Page 1 of 1 (1 locations)

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892