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| Name | Class |
|---|---|
| Hoxworth Blood Center | OTHER |
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The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).
Stem cell transplant reduces your ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study we are trying to find a way to prevent these infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viral Specific T-cells (VSTs) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viral Specific T-cells (VSTs) | Biological | VSTs will be infused into stem cell transplant recipients |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of a Toxicity | Participants will be assessed for the presence of a toxicity. | 30 days |
| Number of Participants With Acute Graft-Vs-Host Disease (aGVHD) | Participants will be assessed for the presence of aGVHD. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of a Viral Infection | Participants will be assessed for the presence of viral infection. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Grimley, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viral Specific T-cells (VSTs) | Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2019 | Nov 9, 2021 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Viral Specific T-cells (VSTs) | Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Presence of a Toxicity | Participants will be assessed for the presence of a toxicity. | Posted | Count of Participants | Participants | 30 days |
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| Primary | Number of Participants With Acute Graft-Vs-Host Disease (aGVHD) | Participants will be assessed for the presence of aGVHD. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Number of Participants With Presence of a Viral Infection | Participants will be assessed for the presence of viral infection. | Posted | Count of Participants | Participants | 30 days |
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30 days
All adverse events that occur from the administration of first VST infusion through 30 days after the last VST infusion were recorded per the protocol. Events occurring greater than 30 days after the last VST infusion were assessed and recorded only when they are unexpected and determined to be at least possibly related to the VST infusion through 1 year after the last VST infusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Viral Specific T-cells (VSTs) | Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients | 2 | 23 | 0 | 23 | 1 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GVHD, skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| GVHD, stomach | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| GVHD, sigmoid colon & rectum | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Grimley, MD | Cincinnati Children's Hospital Medical Center | 513-803-3218 | Michael.Grimley@cchmc.org |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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