Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klaus Herfarth - Dr. J. Debus; Klaus Herfarth, MD
• Collaborators: German Low Grade Lymphoma Study Group; Roche Pharma AG
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• verified follicular lymphoma grade 1 or 2

• only nodal involvement (incl. Waldeyer) clinical stage I or II

• largest tumor ≤ 7 cm

• adequate bone marrow reserves

Exclusion Criteria:

• ECOG >2

• Follicular lymphoma grade 3

• buky disease (>7 cm)

• involvement of the spleen

• neoplasia in PMH (except: basalioma, spinalioma)

• Immunodeficiency syndromes, viral hepatitis, connective tissue disease

• severe psychiatric disease

• pregnancy or breast feeding

• known allergies against foreign proteins