Actively Recruiting
Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
Led by Heidelberg University · Updated on 2026-04-28
100
Participants Needed
12
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)
- Untreated nodal follicular lymphoma, including Waldeyer's ring involvement
- Age 18 years or older
- ECOG performance status 0 to 2
- Clinical stage I or II based on FDG-PET staging
- Largest lymphoma diameter 7 cm or less
- Signed informed consent and willingness to cooperate
- Adequate bone marrow function: ANC 1.5 x 10^3/ml or higher, platelets 100,000 x 10^3/ml or higher, hemoglobin 10 g/dL or higher
- Ability to understand the trial's purpose and consequences
- Use of adequate contraception during therapy and for 18 months after
You will not qualify if you...
- Extra nodal follicular lymphoma involvement
- History of secondary cancer except certain low-risk types diagnosed over 3 years ago
- Serious diseases interfering with regular therapy, including immune deficiency, active infections, uncontrolled cardiovascular or pulmonary disease
- Severe psychiatric illness
- Pregnancy or breastfeeding
- Known allergy to Obinutuzumab, Rituximab, or related drug components
- Active hepatitis B infection (inactive infections require antiviral prophylaxis)
- Participation in another interventional or competing trial
- Elevated creatinine, unless clearance is normal
- Elevated liver enzymes (AST or ALT over 2.5 times normal)
- High bilirubin (1.5 times normal or more)
- Increased clotting times (INR, PTT, or aPTT over 1.5 times normal)
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Vivantes Klinikum Berlin
Berlin, Germany, 10967
Actively Recruiting
2
University of Essen
Essen, Germany, 45147
Actively Recruiting
3
University of Göttingen
Göttingen, Germany, 37075
Actively Recruiting
4
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
5
Strahlentherapie KH Maria Hilf
Mönchengladbach, Germany, 41063
Actively Recruiting
6
LMU München
Munich, Germany, 81377
Actively Recruiting
7
Technische Universität München
Munich, Germany, 81675
Actively Recruiting
8
Krankenhaus Barmherzige Brüder
Regensburg, Germany, 93049
Actively Recruiting
9
University of Rostock
Rostock, Germany, 18057
Actively Recruiting
10
Katharinen Hospital Stuttgart
Stuttgart, Germany
Actively Recruiting
11
University of Tübingen
Tübingen, Germany, 72076
Actively Recruiting
12
University of Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
K
Klaus Herfarth, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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