Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
NCT ID: NCT05045664
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-07-06
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard
Standard dose (24 Gy) involved site radiotherapy plus Rituximab
Standard
12 x 2 Gy involved site radiotherapy plus Rituximab
Standard
Rituximab with 12 x 2 Gy involved site radiotherapy
Experimental
ow-dose (4 Gy) involved site radiotherapy in combination with Obinutuzumab
Experimental
2 x2 Gy involved site radiotherapy plus Obinutuzumab
Experimental
Obinutuzumab with 2 x2 Gy involved site radiotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard
12 x 2 Gy involved site radiotherapy plus Rituximab
Experimental
2 x2 Gy involved site radiotherapy plus Obinutuzumab
Standard
Rituximab with 12 x 2 Gy involved site radiotherapy
Experimental
Obinutuzumab with 2 x2 Gy involved site radiotherapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Klaus Herfarth, MD
Vice Chair, Department of Radiation Oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Klaus Herfarth, MD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christian Scholz, MD
Role: primary
Stefan Rieken, MD
Role: primary
Klaus Herfarth, MD
Role: primary
Ursula Nestle, MD
Role: primary
Martin Dreyling, MD
Role: primary
Simon Heidegger, MD
Role: primary
Bernhard Heilmeier, MD
Role: primary
Guido Hildebrandt, MD
Role: primary
Stefan Wirths, MD
Role: primary
Christian Buske, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Konig L, Dreyling M, Durig J, Engelhard M, Hohloch K, Viardot A, Witzens-Harig M, Kieser M, Klapper W, Pott C, Herfarth K. Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial. Trials. 2019 Aug 30;20(1):544. doi: 10.1186/s13063-019-3614-y.
Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.
Herfarth K, Borchmann P, Schnaidt S, Hohloch K, Budach V, Engelhard M, Viardot A, Engenhart-Cabillic R, Keller U, Reinartz G, Eich HT, Witzens-Harig M, Hess CF, Dorken B, Durig J, Wiegel T, Hiddemann W, Hoster E, Pott C, Dreyling M. Rituximab With Involved Field Irradiation for Early-stage Nodal Follicular Lymphoma: Results of the MIR Study. Hemasphere. 2018 Nov 30;2(6):e160. doi: 10.1097/HS9.0000000000000160. eCollection 2018 Dec.
Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000362-15
Identifier Type: -
Identifier Source: org_study_id