First international Inter-Group Study for nodular lymphocyte predominantHodgkin`s Lymphoma in Children and Adolescents

Phase 1

Conditions: odular lymphocyte-predominant Hodgkin’s lymphoma in childhood and adolescence.
MedDRA version: 17.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-004092-19-FR

Lead Sponsor: Martin Luther University of Halle/Wittenberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 200

Inclusion Criteria

Trial sites register patients at their corresponding study office if the following requirements are met:
• 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
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

Patients with one of the following circumstances are excluded :
• 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)