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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT01088750
Eligibility Criteria:
Inclusion criteria:
* nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.
* initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
* patient aged under 18 years at time of diagnosis
* written informed consent of the patient and/or the patient's parents or guardian according to national laws
Exclusion criteria
* pre-treatment of Hodgkin's lymphoma differing from study protocol
* Any extra-nodal involvement
* Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment
* known hypersensitivity or contraindication to study drugs
* prior chemotherapy or radiotherapy
* Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids
* Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial
* other (simultaneous) malignancies
* severe concomitant diseases (e.g. immune deficiency syndrome)
* known HIV positivity
* pregnancy and / or lactation
* females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT01088750
Study Brief:
Protocol Section:
NCT01088750