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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT07209059
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent prior to any study-specific procedures
* Histologically confirmed classical Hodgkin lymphoma (cHL)
* Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
* At least one measurable lesion ≥15 mm in the longest diameter (by CT)
* Age between 18 and 60 years (inclusive)
* ECOG performance status 0-2
* PET-CT performed at baseline
* No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
* Adequate organ function, including:
* Serum creatinine ≤ 0.2 mmol/L
* Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
* Ability to comply with the study protocol and scheduled visits
Exclusion Criteria:
* Active hepatitis B or C infection
* Positive test for HIV
* Pregnancy or breastfeeding
* Prior or active autoimmune disease requiring systemic therapy
* Vaccination with a live vaccine within 30 days prior to first nivolumab dose
* History of non-infectious pneumonitis requiring corticosteroids
* Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)
* Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias
* Severe renal impairment (serum creatinine \> 0.2 mmol/L), unless lymphoma-related
* Severe hepatic dysfunction, unless directly related to lymphoma
* Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
* Sepsis or hemodynamic instability
* Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
* Cachexia (total serum protein \< 35 g/L), unless due to lymphoma-related liver damage
* Decompensated diabetes mellitus
* Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07209059
Study Brief:
Protocol Section:
NCT07209059