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New treatment option for Hematopoietic and Lymphoid Cell Neoplasm
Official title Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
ClinicalTrials.gov ID: NCT03425526
What this study is testing
What is Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes?
Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as Allogeneic Adenovirus-specific 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
- This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.
- Phase 1: an early, usually small safety study
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
- Immunocompromised patients.
- English and non-English speaking patients.
- Written informed consent and/or signed assent from patient, parent or guardian.
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical...
- Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and...
You likely can't join if
- Patients receiving prednisone \> 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days...
- Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection...
- Active acute graft versus host disease (GVHD) grade \>= 2.
See the full eligibility criteria
- Immunocompromised patients.
- English and non-English speaking patients.
- Written informed consent and/or signed assent from patient, parent or guardian.
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an...
- Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with \>/=...
- Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
- Willingness to comply with the study protocol requirements.
- Patients receiving prednisone \> 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28...
- Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must...
- Active acute graft versus host disease (GVHD) grade \>= 2.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.