classic Hodgkin´s lymphoma
Conditions
Interventions
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Vincristine
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 2-
Pharmaceutical Form: Tablet
INN or Pr
Sponsors
Martin Luther University of Halle/Wittenberg, Medizinische Fakultät, Prodekanat Forschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of classic Hodgkin´s lymphoma, patient aged under 18 years at time of diagnosis, written consent of the patient or the patient´s parent or guardian acording 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: pretreatment of Hodgkin´s lymphoma differing from study protocol, known hypersensitivity or contraindication to study drugs, diagnosis of lymphocyte predominant Hodgin´s lymphoma, prior chemotherapy or radiotherapy, other (simultaneus) malignancies, pregnancy and/or lactation, females who are sexually active refusing to use effective contraception, current or recent treatment with another investigational drug or participation in another investigational trial, severe concomitantn diseases, 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 group after 2 OEPA treated without radiotherapy consistent with a target EFS rate of 90% in all treatment groups? 2.Can Prokarbazinebe safely replaced by Dacarbazinein therapy groups TG2 and TG3 without a deterioration of EFS (randomized comparation of COPDAC and COPP) ? 3.Description of treatment outcome to standardised risk adapted relapse strategy.;Secondary Objective: 1. Is the 5 year event free survival (EFS) rate in patients with inadequate response group after 2 OEPA who received standard consistent with a target EFS rate of 90% estimates in all treatment groups? Does substitution of Dacarbazine for Procarbazine in TG- 2 and 3 patients decrease the rate of infertility in males and preamture 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