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Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428918
Recruitment Status : Withdrawn (The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.)
First Posted : June 11, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

Allogenic hematopoietic cell transplantation (HCT) is a procedure in which a person gets stem cells from a donor in order to treat their disease. Researchers want to collect samples from people who have had or will have HCT. They will perform tests on the samples to study the immune system and its response to infections and disease.

Objective:

To collect biological samples from people who have had or are planning to have HCT to treat primary immunodeficiencies, blood cancers, or disorders of T-cell proliferation and/or dysregulation.

Eligibility:

People age 8 years and older who have undergone or are planning to undergo HCT.

Design:

Participants will be screened with:

Medical history

Medical chart review

Physical exam

Blood tests.

Participants may give blood and urine samples.

Participants may have a skin biopsy.

Participants may undergo apheresis. For this, a needle will be placed into an arm vein to take blood. A machine divides the whole blood into parts. The sample cells are taken out and the rest of the blood is returned through a second needle in the other arm.

Participants may have a bone marrow aspiration and biopsy. For this, the hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.

Participants may have a tumor or other abnormal tissue biopsy. For this, a tissue sample is obtained using a needle and syringe. They will sign a separate consent form. They may have a body scan or ultrasound to help locate the tumor during the biopsy.

Participation lasts for as long as participants choose to give samples.


Condition or disease
Hematopoietic Stem Cell Transplantation Cell Transplantation Hematologic Malignancies

Detailed Description:

Background:

  • Allogenic Hematopoietic Cell Transplantation (HCT) is a potentially curative option for some patients with primary immunodeficiencies (PID) and hematological cancers.
  • HCT for PID looks to restore defects in cells of hematopoietic origin allowing for eradication of protracted or recurrent viral infections.
  • The curative potential of allogenic HCT for hematologic malignancies is mediated by the allogeneic immune system through a graft-versus-tumor (GVT) effect.
  • Characterization of the immunologic landscape in patients with successful eradication of viral infections and hematologic malignancies following allogenic HCT requires further investigation.

Objectives:

-To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with allogenic HCT and perform immunological landscape studies.

Eligibility:

-Patients age greater than or equal to 8 years of age and have undergone or are planning to undergo HCT.

Design:

  • Up to 100 subjects will be enrolled.
  • Patients may undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, skin, mucosa, saliva, stool, sputum, spinal fluid, or other tissues or fluids for banking and laboratory studies.
  • No investigational or experimental therapy will be given as part of this protocol.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
Actual Study Start Date : June 5, 2020
Actual Primary Completion Date : September 17, 2020
Actual Study Completion Date : September 17, 2020

Group/Cohort
Cohort 1
Allogeneic HCT recipient or patient pending receipt of HCT



Primary Outcome Measures :
  1. Sample Aquisition [ Time Frame: Ongoing ]
    To conduct immunological landscape studies on samples collected. To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with allogenic HCT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients age > 8 years of age and have undergone or are planning to undergo HCT. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.
Criteria
  • INCLUSION CRITERIA:
  • Diagnosis of a hematologic malignancy, immunodeficiency or disorder of T-cell proliferation and/or dysregulation
  • Have undergone or planning to undergo an allogenic hematopoietic cell transplantation
  • Age greater than or equal to 8 years
  • Additional inclusion criteria pertinent only for patients undergoing apheresis
  • Hemoglobin greater than or equal to 8 mg/dL and platelet count > 75 K/uL
  • Weight greater than or equal to 48 kg
  • Adequate venous access

EXCLUSION CRITERIA:

  • Active concomitant medical or psychological illnesses that may increase the risk to the subject
  • Inability of subject or parent/legal guardian to provide informed consent
  • Pregnant or breastfeeding women as some tests and procedures allowed are contraindicated in pregnancy (i.e., CT scans, administration of iodinated contrast)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428918


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christian S Hinrichs, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04428918    
Other Study ID Numbers: 200072
20-C-0072
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Immunological
Apheresis Products
Protein
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases