HOVON HO35 NHL
- HO35 NHL / EORTC 20963
- Included patients:
- Active sites:
0(of 27)27 sites are pending
Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation followed by Interferon-Alpha Maintenance Treatment versus Interferon-Alpha Maintenance Treatment alone after a Chemotherapy-Induced Remission in Patients with Stages III or IV Follicular Non-Hodgkin's Lymphoma: A Prospective, Randomized, Phase III Clinical Trial - Intergroup collaborative study (EORTC 20963).
- Prospective randomized Phase III study
- Monitoring Type:
- Inclusion Criteria:
- Previously untreated patients with follicular NHL presenting with stages III or IV, including nodal, Waldeye's ring and extranodal localisations.
- Follicular NHL according to the: - REAL classification (follicle center lymphoma, follicular provisional cytologic grades: I, II, III) - International Working Formulation (Groups B, C, D) - Kiel Classification (malignant lymphoma)
- Age above 18 years and below 66 years.
- WHO performance Status grade 0, 1 or 2.
- Patient information and informed consent according to the rules of the respective country.
- Exclusion Criteria:
- Patients with severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease.
- Serum creatinine, BUN, alkaline phoshatase or bilirubin: = 2.5 times the upper limit of the normal value, unless clearly related to NHL.
- Pregnant women.
- Patients with prior malignancies except non-melanoma skin tumors or stage 0 cervical carcinoma.
- Patients with HIV positivity.
- Patients who are unable to attend regular outpatient appointments for treatment and treatment evaluation.