Hematopoietic Stem Cell TransplantationNCT04428918
Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
An observational study of Hematopoietic Stem Cell Transplantation and Cell Transplantation, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cell Transplantation, Hematologic Malignancies
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 17 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
- Keywords
- Immunological, Apheresis Products, Protein
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Allogeneic HCT recipient or patient pending receipt of HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start5 Jun 2020
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Why it stopped: The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christian S Hinrichs, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428918
- Sponsor's protocol ID
- 200072
- Other IDs
- 20-C-0072
- Status last verified
- Sep 2020
- First submitted
- 11 Jun 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT04428918
- Acronym / sponsor ID
- 200072
- Keywords
- Immunological, Apheresis Products, Protein
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Allogeneic HCT recipient or patient pending receipt of HCT |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Hinrichs, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation and Cell Transplantation, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample Aquisition (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.