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Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

RecruitingPhase 3Ages 18 Years - anyAllHeidelberg University
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In plain words

What the trial is, and whether it could suit you

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 us

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Standard
  • Experimental
  • Standard
  • Experimental
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Where

12 sites
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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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