NCT05045664

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems to show a high CR rate based on the 50% of the patients. This is in contrast to the FORT trial, which showed an inferiority of the 4 Gy dose compared to the standard dose (24 Gy) in terms of response and progression free survival. The goal of the FORTplus trial is to prove (1) the non-inferiority of LDRT (4Gy) in a combined approach with an anti-CD20-antibody. In case of non-inferiority, a possible (2) superiority of the Obinutuzumab + LDRT should be tested against Rituximab + standard dose using the same test set. The radiation dose can significantly be reduced to 16% of the standard dose if (1) is confirmed. Knowing the data of the FORT trial, this would have a significant influence on the treatment of the disease worldwide even if the difference in the CR rate at week 18 is not as high as currently in the historical comparison expected.

Conditions

• Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a

Interventions

Type	Name	Description
RADIATION	Standard	12 x 2 Gy involved site radiotherapy plus Rituximab
RADIATION	Experimental	2 x2 Gy involved site radiotherapy plus Obinutuzumab
DRUG	Standard	Rituximab with 12 x 2 Gy involved site radiotherapy
DRUG	Experimental	Obinutuzumab with 2 x2 Gy involved site radiotherapy

Timeline

• Start date: 2022-07-06
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2021-09-16
• Last updated: 2024-12-06

Locations

12 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study