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RECRUITING

NCT05045664

PHASE3

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

Sponsor: Heidelberg University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-07-06

Completion Date

2029-12-31

Last Updated

2024-12-06

Healthy Volunteers

Conditions

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

Interventions

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

Inclusion Criteria: * • 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 Exclusion Criteria: * Extra nodal manifestation of follicular lymphoma * 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) * 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 * Severe psychiatric disease * Pregnancy / lactation * 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) * Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial * 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

Locations (12)

Vivantes Klinikum Berlin

Berlin, Germany

University of Essen

Essen, Germany

University of Göttingen

Göttingen, Germany

University Hospital Heidelberg

Heidelberg, Germany

Strahlentherapie KH Maria Hilf

Mönchengladbach, Germany

LMU München

Munich, Germany

Technische Universität München

Munich, Germany

Krankenhaus Barmherzige Brüder

Regensburg, Germany

University of Rostock

Rostock, Germany

Katharinen Hospital Stuttgart

Stuttgart, Germany

University of Tübingen

Tübingen, Germany

University of Ulm

Ulm, Germany