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Compares treatment options for Allogeneic Stell Cell Transplant
Official title Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
ClinicalTrials.gov ID: NCT04230356
What this study is testing
What is Viral Specific T-cells (VSTs) Scheduled?
Viral Specific T-cells (VSTs) Scheduled is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for allogeneic stell cell transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- SCHEDULED ARM:
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
- No critical illness making VST infusion hazardous
You likely can't join if
- Active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy.
- Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell...
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 9,000
See the full eligibility criteria
- SCHEDULED ARM:
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
- No critical illness making VST infusion hazardous
- Active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy.
- Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their...
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 9,000
- Plasma BKV PCR \>1,000
- Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx...
- Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
- Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever...
- Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.
- No active acute GVHD grades II-IV
- No uncontrolled relapse of malignancy
- No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
- Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.