RECRUITING

Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

Conditions

Graft-Versus-Host Disease Graft-versus-leukemia Donor Apheresis G-CSF Graft Versus Host Disease graft versus leukemia Natural History Normal Volunteer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old. One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death. In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD. The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells. In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells. The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.

Official Title

Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation

Quick Facts

Study Start:1996-03-18

Study Completion:N/A

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00001529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy individual aged 18 to 60 years. * No active infection or history of recurrent infection. * Normal renal function: creatinine \<1.5 mg/dL or estimated glomerular filtration rate (eGFR) \>=60 mL/min/1.73 m\^2, with no significant proteinuria. * Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke. * Healthy female subjects of childbearing age should have a negative serum pregnancy test with one week of beginning G-CSF administration. * Female subjects should not be lactating. * Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test. * Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol. * Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry.	* Active viral, bacterial, fungal or parasite infection. * Female with positive pregnancy test or lactating. * Active or moderate-to-severe autoimmune disease that is currently treated or expected to require immunosuppressive therapy. Candidates with stable, well-controlled mild autoimmune disease may be considered on a case-by-case basis. * Active or recent malignancy within the past 5 years. Individuals with remote (\>5 years) histories of low-risk malignancies in remission (e.g., localized prostate cancer) or treated basal cell carcinoma may be included. * History of any hematologic disorders. * History of clinically significant cardiovascular disease (e.g., symptomatic coronary artery disease, uncontrolled hypertension). Minor risk factors must be evaluated on a case-by-case basis (e.g., controlled hypertension). * Any positive serum screening test as listed in eligibility. * Allergy to G-CSF or bacterial E coli products. * Administration of NSAID within. 5-7 days of starting the protocol, depending on drug half-life. * History of G-CSF administration and leukapheresis within past 3 months.

Inclusion Criteria

Exclusion Criteria

* Healthy individual aged 18 to 60 years.
* No active infection or history of recurrent infection.
* Normal renal function: creatinine \<1.5 mg/dL or estimated glomerular filtration rate (eGFR) \>=60 mL/min/1.73 m\^2, with no significant proteinuria.
* Normal cardiovascular function, no history of chest pain, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke.
* Healthy female subjects of childbearing age should have a negative serum pregnancy test with one week of beginning G-CSF administration.
* Female subjects should not be lactating.
* Subject must be eligible for normal blood donation. He or she must be tested negative for syphilis (RPR), hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV, HTLV-1, West Nile virus, T. Cruzi and Babesia test.
* Subject must be able to comprehend the investigational nature of the study and provide informed consent to participate in the protocol.
* Antecubital veins must be adequate for peripheral access during apheresis. Potential participants must be screened by an apheresis nurse to check venous access before protocol entry.

* Active viral, bacterial, fungal or parasite infection.
* Female with positive pregnancy test or lactating.
* Active or moderate-to-severe autoimmune disease that is currently treated or expected to require immunosuppressive therapy. Candidates with stable, well-controlled mild autoimmune disease may be considered on a case-by-case basis.
* Active or recent malignancy within the past 5 years. Individuals with remote (\>5 years) histories of low-risk malignancies in remission (e.g., localized prostate cancer) or treated basal cell carcinoma may be included.
* History of any hematologic disorders.
* History of clinically significant cardiovascular disease (e.g., symptomatic coronary artery disease, uncontrolled hypertension). Minor risk factors must be evaluated on a case-by-case basis (e.g., controlled hypertension).
* Any positive serum screening test as listed in eligibility.
* Allergy to G-CSF or bacterial E coli products.
* Administration of NSAID within. 5-7 days of starting the protocol, depending on drug half-life.
* History of G-CSF administration and leukapheresis within past 3 months.

Contacts and Locations

Study Contact

Richard A Gustafson, R.N.

CONTACT

(301) 402-5822

richard.gustafson@nih.gov

Andre Larochelle, M.D.

CONTACT

(301) 451-7139

larochea@nhlbi.nih.gov

Principal Investigator

Andre Larochelle, M.D.

PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Andre Larochelle, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1996-03-18

Study Completion DateN/A

Study Record Updates

Study Start Date1996-03-18

Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

G-CSF
Donor Apheresis
Graft Versus Host Disease
graft versus leukemia
Natural History
Normal Volunteer

Additional Relevant MeSH Terms

Graft-Versus-Host Disease
Graft-versus-leukemia
Donor Apheresis