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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT07171827
Eligibility Criteria:
Inclusion Criteria:
* Age: 18- 70 Years.
* Histopathology: confirmed classical Hodgkin Lymphoma according to the current World Health Organization (WHO) classification. CD30 positive by immunohistochemistry.
* Stage III or IV Hodgkin lymphoma (HL) by the Ann Arbor classification system.
* Treatment-naïve.
* Laboratory:
* complete blood count: absolute neutrophil counts (≥1500 per cubic millimeter), platelet counts (≥75,000 per cubic millimeter), and hemoglobin levels (≥8 g per deciliter) (except for patients with involvement of the marrow).
* liver function test: total bilirubin level \<1.5 times the upper limit of normal and alanine aminotransferase or aspartate aminotransferase levels \<3 times the upper limit of normal.
* kidney function test: serum creatinine level, \<2.0 mg per deciliter or creatinine clearance or calculated creatinine clearance, \>40 ml per minute.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria:
* Histopathology: Nodular lymphocyte predominant Hodgkin lymphoma and non-Hodgkin lymphoma.
* Cerebral/meningeal disease.
* Prior treatment with chemotherapy, radiotherapy, or any immunotherapy within 12 weeks of first study drug dose.
* Known human immunodeficiency virus (HIV) positive, known hepatitis B surface antigen-positive, or known active hepatitis C infection.
* Known organ failure.
* Cardiac: left ventricular ejection fraction \< 50%, myocardial infarction within 2 years of randomization or current uncontrolled cardiovascular conditions, including arrhythmias, congestive heart failure, angina, evidence of acute ischemia, or active conduction system abnormalities.
* Female patients who are breastfeeding or having a positive serum pregnancy test during the randomization period or on day 1 before starting treatment.
* Neurotoxicity, including symptomatic neurologic disease, comprising normal daily activities, any sensory or motor peripheral neuropathy.
* Pulmonary diffusion capacity \>25 % lower than predicted value as retrieved by pulmonary function test for each patient before randomization.
* Known hypersensitivity to recombinant proteins, murine proteins, or any component of the included drugs formulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07171827
Study Brief:
Protocol Section:
NCT07171827