Drug intelligence / Profile preview

rituximab + radiotherapy

Development stage
Unknown
Lead developer
Heidelberg University Hospital
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Involved-site Radiotherapy
01

Overview

Standard-Heidelberg University-follicular lymphoma refers to the standard treatment arm of the Phase 3 FORTplus clinical trial (NCT05045664) conducted by Heidelberg University. This regimen is designed for patients with untreated early-stage (Stage I or II) nodal follicular lymphoma (grades 1, 2, or 3a). It consists of a combination of the anti-CD20 chimeric monoclonal antibody rituximab and standard-dose involved-site radiotherapy (ISRT). Rituximab is administered at a dose of 375 mg/m² for a total of eight doses (weeks 1-4 and 9-12), while the radiotherapy component delivers a total dose of 24 Gy in 12 fractions of 2 Gy each during weeks 9-11. The regimen aims to achieve systemic B-cell depletion through rituximab's targeting of CD20-positive cells and localized tumor control via ionizing radiation. In the FORTplus trial, this standard approach is being compared against an experimental arm utilizing obinutuzumab plus low-dose (4 Gy) radiotherapy to evaluate non-inferiority and potential toxicity reduction.

Other names
Standard-Heidelberg University-follicular lymphomaStandard arm of FORTplus trialStandard-dose radiotherapy plus rituximab
02

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