EuroNet-Paediatric Hodgkin's Lymphoma Group / First International inter-group study for classical Hodgkin’s lymphoma in children and adolescents - EURONET PHL C1

Phase 1

• Conditions: Classical Hodgkin's Lymphoma in children and adolescents; MedDRA version: 8.1 Level: PT Classification code 10025319 Term: Classical Hodgkin's Lymphoma in children and adolescents

• Registration Number: EUCTR2006-000995-33-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2200

Inclusion Criteria

Trial sites register patients at their corresponding study office if the following requirements are met:
- diagnosis of classic Hodgkin's lymphoma
- 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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with one of the following circumstances are excluded:
- pre-treatment of Hodgkin's lymphoma differing from study protocol (except recommended pre-phase therapy of a large mediastinal tumour)
- Known hypersensitivity or contraindication to study drugs
- diagnosis of lymphocyte predominant Hodgkin's lymphoma
- prior chemotherapy or radiotherapy
- other (simultaneous) malignancies
- 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)
- current or recent (within 30 days prior to start of trial treatment) treatment with another investigonal drug or participation in another investigational trial
- severe concomitant diseases ( e.g. immune deficiency syndrome)
- known HIV positivity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified