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New treatment option for CMV
Official title Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
ClinicalTrials.gov ID: NCT04056533
What this study is testing
What is CMV CTLs?
CMV CTLs is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cmv.
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
- Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT.
- 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 18 to 80
You may be able to join if
- Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
- Any source of stem cells (peripheral blood or bone marrow).
- CMV-seropositive donors.
- Negative pregnancy test in women.
- Signed writen informed consent.
You likely can't join if
- Patients without haploidentical CMV-seropositive donors.
- Patients who are not suitable for follow up visits. CMV-CTLs Infusion Criteria:
- Hematopoiesis recovery at least partial (neutrophil counts \>0.5x10\^9/L in at least 3 consecutive samples post-transplant). CMV-CTLs NON-Infusion...
- Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
- ECOG \> or = 3.
- Organic toxicities grade \> or = 3.
See the full eligibility criteria
- Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
- Any source of stem cells (peripheral blood or bone marrow).
- CMV-seropositive donors.
- Negative pregnancy test in women.
- Signed writen informed consent.
- DONORS:
- HLA haploidentical and CMV-seropositve donors.
- Donor must be checked and suitable.
- Signed writen informed consent.
- Donor without active infection evidence at leukapheresis.
- Patients without haploidentical CMV-seropositive donors.
- Patients who are not suitable for follow up visits. CMV-CTLs Infusion Criteria:
- Hematopoiesis recovery at least partial (neutrophil counts \>0.5x10\^9/L in at least 3 consecutive samples post-transplant). CMV-CTLs NON-Infusion Criteria:
- Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
- ECOG \> or = 3.
- Organic toxicities grade \> or = 3.
- Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.
- Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.
- Persistent fevers 3 days before infusion.
- Acute Graft Versus Host Disease (GVHD) grade II-IV.
- Relapse or progression after transplant and before infusion day.
- CMV reactivation/infection after transplant and before infusion day. Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Santander, Spain
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santander, Spain. 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.