First International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents

Phase 1

• Conditions: Classic Hodgkin’s lymphoma in childhood and adolescence; MedDRA version: 13.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-000995-33-GB
• Lead Sponsor: Martin Luther University of Hallle/Wittenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-10
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

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:
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