Classic Hodgkin’s lymphoma in childhood and adolescence MedDRA version: 13.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Procarbazine
Pharmaceutical Form: Capsule
INN or Proposed INN: PROCARBAZINE
CAS Number: 671169
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pr
Sponsors
Martin Luther University of Hallle/Wittenburg
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. To determine whether 5 year event free survival (EFS) in patients with adequate response after 2 OEPA courses remains at the target of 90% in patients where radiotherapy is omited. 2. To determine whether procarbazine can be replaced with dacarbazine (randomised comparison of COPP vs COPDAC) without a deterioration in EFS 3. Standardisation of relapse strategy ;Secondary Objective: 1. To determine whether 5 year event free survival (EFS), in patients with inadequate response after 2 OEPA courses but who receive standard radiotherapy, remains at the target of 90%. 2. To determine whether substitution of procarbazine by dacarbazine decreases the rate of infertility in males and premature menopause in females in patients. 3. Exploration of the impact of real-time central staging and response assessment on treatment outcome. ;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, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed