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: 8.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease
Conditions
Interventions
Pharmaceutical Form: Capsule*
INN or Proposed INN: Procarbazine
CAS Number: 366-70-1
Other descriptive name: Procarbazine
Concentration
Sponsors
Martin-Luther-University Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 EFS rate of 90% in all treatment groups? 2. Can Procarbazine be safely replaced by Dacarbazine in therapy groups TG-2 and TG-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: 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 all treatment groups? 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