Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT04056533
Eligibility Criteria:
Inclusion 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:
1. HLA haploidentical and CMV-seropositve donors.
2. Donor must be checked and suitable.
3. Signed writen informed consent.
4. Donor without active infection evidence at leukapheresis.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04056533
Study Brief:
Protocol Section:
NCT04056533