Allogeneic Stem Cell Transplant, Viral Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALViral Specific T-cells (VSTs)
VSTs will be infused into stem cell transplant recipients
Sponsors
Hoxworth Blood Center
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Recipient must be at least 21 days after stem cell infusion * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
Exclusion criteria
* Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs * Active acute GVHD grades II-IV * Uncontrolled relapse of malignancy * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. The level must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of a Toxicity | 30 days | Participants will be assessed for the presence of a toxicity. |
| Number of Participants With Acute Graft-Vs-Host Disease (aGVHD) | 30 days | Participants will be assessed for the presence of aGVHD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of a Viral Infection | 30 days | Participants will be assessed for the presence of viral infection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Viral Specific T-cells (VSTs) Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Viral Specific T-cells (VSTs) |
|---|---|
| Age, Categorical <=18 years | 27 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 23 |
| other Total, other adverse events | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)
Participants will be assessed for the presence of aGVHD.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Specific T-cells (VSTs) | Number of Participants With Acute Graft-Vs-Host Disease (aGVHD) | 2 Participants |
Primary
Number of Participants With Presence of a Toxicity
Participants will be assessed for the presence of a toxicity.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Specific T-cells (VSTs) | Number of Participants With Presence of a Toxicity | 0 Participants |
Secondary
Number of Participants With Presence of a Viral Infection
Participants will be assessed for the presence of viral infection.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viral Specific T-cells (VSTs) | Number of Participants With Presence of a Viral Infection | 14 Participants |