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

Phase 1

• Conditions: The first line therapy for childhood nodular lymphocyte-predominant Hodgkin’s lymphoma shall be further optimised to avoid over-treatment and decrease long-term complications.; MedDRA version: 14.0Level: HLTClassification code 10020226Term: Hodgkin's disease lymphocyte predominance typeSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004092-19-DE
• 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: 2009-03-10
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•first diagnosis of nodular lymphocyte-predominant Hodgkin’s lymphoma confirmed by reference pathology or patients relapsing after surgery alone with relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned.
•stage IA/IIA (according to local staging)
•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: 200
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

•diagnosis of classical Hodgkin’s lymphoma
•pre-treatment of Hodgkin’s lymphoma differing from study protocol
•nodular lymphocyte-predominant Hodgkin’s lymphoma above stage IA/IIA
•Any extra-nodal involvement
•Lack of availability of all imaging techniques required for complete state of the art staging and response assessment (CT, MRI, FDG-PET) for the patient.
•known hypersensitivity or contraindication to study drugs
•prior chemotherapy or radiotherapy
•Current or recent (within 30 days prior to the start of trial treatment) therapy with a course or pulse of 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)

Study & Design

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