Main info

Identificatie:

HO35 NHL / EORTC 20963

Sponsor:

HOVON

Included patients:

65

Active sites:

0

(of 27)

27 sites are pending

Title:

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).

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

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.

Participating Sites

= Active hospitals

= Inactive hospitals