NCT05045664RecruitingPhase 3
Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Aug 2021
- Start date
- 6 Jul 2022
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Heidelberg University
- Diseases
- Follicular lymphoma
- NCT number
- NCT05045664
- EU CT number
- 2023-509278-41-00
- EudraCT number
- 2021-000362-15
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 6 Jul 2022 to the primary completion date, 30 Sept 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease
Other illness
- Severe psychiatric disease
- Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug
- Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)
Lab values
- Creatinine \> 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance \< 40 mL/min
- AST or ALT \> 2.5 × ULN
- Total bilirubin ≥ 1.5 × ULN
- INR \> 1.5 × ULN
- PTT or aPTT \> 1.5 × the ULN
Age
- Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed \>3 years ago)
Other
- Extra nodal manifestation of follicular lymphoma
- Pregnancy / lactation
- Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial
Who the study is looking for
- • Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)
- Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)
- Age: ≥18 years
- ECOG: 0-2
- Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging
- Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)
- Written informed consent and willingness to cooperate during the course of the trial
- Adequate bone marrow capacity: ANC ≥ 1.5 x 103/ml, thrombocytes ≥ 100000 x 10 3/ml, hemoglobin ≥ 10 g/dL
- Capability to understand the intention and the consequences of the clinical trial
- Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vivantes MVZ GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Kliniken Maria Hilf GmbH Moenchengladbach Coordinator of this site? Confirm its status | Moenchengladbach | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Recruiting |
| Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.