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:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT02007356
Eligibility Criteria:
Inclusion Criteria:
* Adults \> 18 years of age
* Undergone allogeneic HSCT
* Written informed consent
* Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:
Patient with Adenovirus Infection:
1. Antiviral treatment with cidofovir for at least 7 days
* no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or
* cluster of differentiation 3 (CD3) + cells \< 300/µL on treatment for at least 7 days
2. Or if antiviral treatment is contraindicated
Patient with EBV:
1\. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)
* No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or
* CD3+ cells \< 300/µL 7 days after receipt of treatment or
* Clinical progression
Patient with CMV:
1. Antiviral treatment with ganciclovir or foscavir for 14 days
\- No Virus load decrease (≤ 1 log) or virus load increase on day 14
2. Or if \> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \< 300/µL
3. Or if antiviral treatment is contraindicated -
Patient Exclusion Criteria:
* graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
* Known allergy to iron-dextran or murine antibodies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02007356
Study Brief:
Protocol Section:
NCT02007356