EuroNet-Paediatric Hodgkin’s Lymphoma Group Second trial conducted by European experts in the field for treating Classical Hodgkin’s Lymphoma in Children and Adolescents

Phase 1

• Conditions: Hodgkin lymphoma in children and adolescents; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004053-88-BE
• Lead Sponsor: Justus-Liebig-University Giessen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-20
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

•histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
•patients under 18 years of age on the date of written informed consent. In specialized Teenage and Young Adult (TYA) units in France, Italy and UK patients up to under 25 years of age can also be enrolled. Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
•written informed consent of the patient and/or the patient’s parents or guardian according to national laws
•negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential

Are the trial subjects under 18? yes
Number of subjects for this age range: 2200
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

•prior chemotherapy or radiotherapy for other malignancies
•pre-treatment of Hodgkin’s lymphoma (except for 7-10 days steroid pre-phase of a large mediastinal tumour)
•diagnosis of lymphocyte-predominant Hodgkin’s lymphoma
•other (simultaneous) malignancies
•contraindication or known hypersensitivity to study drugs
•severe concomitant diseases (e.g. immune deficiency syndrome)
•known HIV-positivity
•residence outside the participating countries where long term follow-up cannot be guaranteed
•pregnancy and/or lactation
•patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
•current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial

Study & Design

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