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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT05757466
Eligibility Criteria:
Inclusion Criteria:
* Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
* Age 18-70 y
* Ejection fraction not less than 50%
* No severe concurrent illness
* 0-2 ECOG status
* Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug.
Exclusion Criteria:
* Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms;
* Respiratory failure \> grade 1 at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Active or prior documented autoimmune disease requiring systemic treatment
* Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
* Hypersensitivity or allergy to study drugs
* Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
* Simultaneous use of drugs or medical devices studied in other clinical trials
* Use of PD-1 inhibitors or bendamustine in the 1st line of therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05757466
Study Brief:
Protocol Section:
NCT05757466