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WithdrawnNCT04428918Updated Sep 22, 2020

Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

An observational study in Hematopoietic Stem Cell Transplantation, Cell Transplantation and Hematologic Malignancies, sponsored by National Cancer Institute (NCI). Withdrawn at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by National Cancer Institute (NCI) · Observational

Why this study was withdrawn
The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
8 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hematopoietic Stem Cell Transplantation
  • Cell Transplantation
  • Hematologic Malignancies

Keywords

  • Immunological
  • Apheresis Products
  • Protein
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

Browse Hematologic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Cohort 1

    Allogeneic HCT recipient or patient pending receipt of HCT

06

What researchers measure

Primary outcomes

  1. Sample Aquisition

    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.

    Time frame: Ongoing

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04428918
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Jun 5, 2020
Primary completion
Sep 17, 2020
Completion
Sep 17, 2020
Last update
Sep 22, 2020

Study contacts

Christian S Hinrichs, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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