Hodgkin Lymphoma
Conditions
Keywords
intermediate stages
Brief summary
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma
Interventions
DRUGprednisone
DRUGvinblastine
DRUGdoxorubicin
DRUGgemcitabine
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of Hodgkin's lymphoma 2. Stage * Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below * Clinical Stage IIB with one or both risk factors c-d given below risk factors: * Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray) * Extranodal involvement * High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms) * Three or more involved lymph node areas 3. No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation) 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.
Exclusion criteria
1. Incomplete diagnosis of stage of disease 2. Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications: * Chronic obstructive pulmonary disease with global insufficiency * Symptomatic coronary heart disease * Cardiomyopathy or cardiac insufficiency (NYHA value of EF \< 50% or FS \< 25%) * Serious uncontrolled hypertension * Uncontrollable infection * Leucocyte concentration \< 3.000/mm3 or thrombocyte concentration \< 100.000/mm3 * Creatinin clearance \< 60 ml/min * Bilirubin \> 2 mg/dl or GPT \> 100 U/l or GOT \> 100 U/I (exception: elevated values of Hodgkin's disease liver involvement) * HIV-Infection according to HIV test * Chronic or acute Hepatitis 3. HD as composite lymphoma 4. Prior chemotherapy or radiation 5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1) 6. Pregnancy, lactation, positive pregnancy test 7. Refusal to use effective contraception 8. WHO performance index \> 2 9. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate) 10. Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly 11. Non compliance: 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 12. Antiepileptic treatment 13. General intolerance of any protocol medication 14. Any contraindication for study medication according to the summaries of product information 15. Simultaneous participation in another clinical 16. Institutionalization by law 17. Relation of dependence with the sponsor's representative / trialist
Countries
Germany
Outcome results
None listed