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
Conditions
Interventions
Trade Name: DOXORUBICINE
Product Name: DOXORUBICINE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicine Hydroch
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the EuroNet-PHL-C1 study are: 1) Are 5 year event free survival (EFS) rate estimates in patients with adequate response after 2 OEPA treated without radiotherapy consistent with a target event free survival (EFS) rate of 90% in TG-1 and TG-2 & TG-3? 2) Can Procarbazine be safely replaced by Dacarbazine in therapy groups 2 and 3 without a deterioration of EFS (randomised comparison of COPDAC and COPP)? 3) Description of treatment outcome to a standardised risk adapted relapse strategy ; Secondary Objective: In addition, the following secondary study objectives are of interest: 1) Is the 5 year event free survival (EFS) rate in patients with inadequate response after 2 OEPA who receive standard involved field radiotherapy consistent with a target EFS rate of 90% estimates in TG-1 and TG-2 & TG-3 ? 2) Does substitution of Dacarbazine for procarbazine in TG-2 and -3 patients decrease the rate of infertility in males and premature menopause for females? ; Primary end point(s): Event free survival (EFS) defined as time from registration until the first of the following events: - Progression/relapse of disease - Diagnosis of a secondary malignancy - Death of any cause | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Netherlands, Poland, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed