Evaluation of the therapy of Hodgkin's Lymphoma in Children and Adolescents

Phase 1

• Conditions: 1st and 2nd line therapy for childhood Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.; MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-000995-33-AT
• Lead Sponsor: Martin Luther University of Halle/Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1800

Inclusion Criteria

• 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: 1800
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

• 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 investigational 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