First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin’s Lymphoma in Children and Adolescents

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

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
In certain European countries very young patients may have to be excluded in order to comply with national laws or formal insurance requirements.

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Subsequent exclusion criteria:
Patients are excluded from the study after registration if:
• Documents or material ascertained before study inclusion show that an exclusion criterion was fulfilled or an inclusion criterion was not met
• The patient and/or the patient’s parents or guardian withdraw(s) his/her/their consent to further study participation.

If central review results in upstaging above stage IA/IIA the patient is still documented in the scope of the study but not eligible for treatment in the study. The patient’s physician then decides together with the patient/parents or guardian as to the most appropriate therapy.
The study chairpersons decide on the exclusion along with the biometrician of the study. Subsequent exclusion of a patient can be requested by a trial site only in writing.
Subsequent exclusion of a patient differs from an individual therapy withdrawal. In the latter case the treatment of the patient according to protocol is terminated, but follow-up and documentation (data collection in the CRF) is continued according to protocol and the patient appears in all relevant analyses.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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