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New treatment option for Epstein-Barr Virus Infections
Official title EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
ClinicalTrials.gov ID: NCT03266653
What this study is testing
What is cytotoxic t-lymphocytes?
cytotoxic t-lymphocytes is an investigational medicine, being studied as a potential treatment for epstein-barr virus infections.
Also referred to as CTLs.
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
- Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
- 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
Ages 1 to 79
You may be able to join if
- 1\. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with:
- Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
- progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND/OR
- Medical intolerance to anti-viral therapies including:
- intolerance to rituximab Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures...
You likely can't join if
- A patient meeting any of the following criteria is not eligible for the present study:
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone...
- Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Valhalla, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 1 month to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Valhalla, New York, United States; Columbus, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.