Completed

Lymphocytapheresis of Patients With Pancytopenia

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Cytopenia+5

+ Anemia

+ Bone Marrow Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: April 1986
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: August 21, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 1986

Actual date on which the first participant was enrolled.

Patients with aplastic anemia, myelodysplasia, and other marrow failure syndromes have a variety of immunologic abnormalities including lymphocyte phenotypic and lymphokine production dysregulation. Because of their low blood counts, it has been difficult to obtain sufficient peripheral blood mononuclear cells for research studies. Patients agreeing to this protocol will be lymphapheresed the equivalent of one or two units of cells (approximately 1-2 x 10(8) cells), which will be used for research purposes.

NCT00001214
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: August 21, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAnemiaBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersAnemia, AplasticPancytopenia

Criteria

INCLUSION CRITERIA: All patients with aplastic anemia or other bone marrow failure in which we would not expect to obtain 1 X 10(8) mononuclear cells from 100 mls of peripheral blood (i.e. an absolute lymphocyte count approximately less than 2000 per mm(3)). Age greater than or equal to 18. EXCLUSION CRITERIA: Patients unable to comprehend the investigational nature of the procedure. Patients unable to tolerate a temporary reduction of blood volume the equivalent of one unit of blood.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center