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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT01920932
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
* Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday).
* Ann Arbor stage IIB, IIIB, IVA, or IVB.
* Adequate renal function based on GFR ≥ 70 ml/min/1.73m\^2 or serum creatinine adjusted for age and gender.
* Adequate hepatic function (total bilirubin \< 1.5 x ULN for age, and SGOT/SGPT \< 2.5 x ULN for age).
* Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
* Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Exclusion Criteria:
* CD30 negative HL.
* Has received prior therapy for Hodgkin lymphoma, except as noted above.
* Inadequate organ function as described above.
* Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01920932
Study Brief:
Protocol Section:
NCT01920932