Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT04428918
Status:
WITHDRAWN
Last Update Posted:
2020-09-22
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20-C-0072 | None | None | View |