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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT06812858
Eligibility Criteria:
Inclusion Criteria:
* 18-70 years;
* Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;
* High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed)
* Complete or partial response by PET/CT after auto-HSCT
* No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
* Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L);
* ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI
Exclusion Criteria:
* Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy;
* Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN;
* Respiratory failure of more than 1 degree at the time of inclusion in the study;
* Unstable haemodynamics at the time of inclusion in the study;
* Acute bacterial, viral or fungal infection at the time of inclusion;
* Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible);
* Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period;
* Somatic or psychiatric pathology that prevents the signing of informed consent;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06812858
Study Brief:
Protocol Section:
NCT06812858