Hodgkin`s lymphoma, intermediate stage
Conditions
Interventions
Trade Name: Prednisone acis® 5 mg
Product Name: Prednisone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of Hodgkin's lymphoma 2. Clinical Stage IA, IB, IIA with at least one of the riskfactors a-d given below, or Clinical Stage IIB with one or both riskfactors c-d given below Riskfactors:a) Large mediastinal mass (= 1/3 of the greatest thorax diameter as measured by chest x-ray), b) Extranodal involvement, c) High erythrocyte sedimentation rate (= 50 mm/h in patients without B-symptoms, = 30 mm/h in patients with B-symptoms), d) Three or more involved lymph node areas 3. No prior therapy for Hodgkin's lymphoma 4. Age: 18-60 years 5. Signed informed consent with understanding of the study procedures and the investigational nature of the study. 6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured) 7. Life expectancy > 3 months according to investigator judgement. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: 1. Incomplete diagnosis of stage of disease 2. Prior or concurrent disease which prevents treatment according to protocol 3. HD as composite lymphoma 4. Prior chemotherapy or radiation 5. Malignant disease within the last 5 years 6. Pregnancy, lactation 7. WHO performance index > 2 8. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate) 9. Non compliance 10. Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible 11. Antiepileptic treatment 12. General intolerance of any protocol medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this trial are to assess the toxicity and activity of PVAG-14 in patients with intermediate-stage Hodgkin's lymphoma. ;Secondary Objective: The secondary objectives are to estimate feasibility, efficacy and safety of PVAG-14 in patients with intermediate-stage Hodgkin's lymphoma. ;Primary end point(s): - Incidence of hematological toxicity grade III/IV - Complete tumor response rate | — |
Countries
Germany
Outcome results
None listed