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Early Stage Follicular Lymphoma WHO Grade 1/2 or 3aPhase 3FORTplusNCT05045664

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

A Phase 3 study testing Standard and Experimental in people with Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a, run by Heidelberg University at 12 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard and Experimental
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
12 sitesGermany
Study dates
6 Jul 2022to 30 Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Klaus Herfarth, MD contact

+496221568202

klaus.herfarth@med.uni-heidelberg.de

12 sites in 1 country

Germany12 sites, 12 recruiting

  • Vivantes Klinikum Berlin

    Berlin, 10967

    Christian Scholz, MD, christianw.scholz@vivantes.de

    Recruiting

  • University of Essen

    Essen, 45147

    Recruiting

  • University of Göttingen

    Göttingen, 37075

    Stefan Rieken, MD, stefan.rieken@med.uni-goettingen.de

    Recruiting

  • University Hospital Heidelberg

    Heidelberg, 69120

    Klaus Herfarth, MD, +496221568202, klaus.herfarth@med.uni-heidelberg.de

    Julia Meissner, MD

    Recruiting

  • Strahlentherapie KH Maria Hilf

    Mönchengladbach, 41063

    Ursula Nestle, MD, +49-2161-8921801, Ursula.nestle@mariahilf.de

    Recruiting

  • LMU München

    Munich, 81377

    Martin Dreyling, MD, Martin.dreyling@med.uni-muenchen.de

    Recruiting

  • Technische Universität München

    Munich, 81675

    Simon Heidegger, MD, Simon.heidegger@tum.de

    Recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

    Bernhard Heilmeier, MD, Bernhard.Heilmeier@barmherzige-regensburg.de

    Recruiting

  • University of Rostock

    Rostock, 18057

    Guido Hildebrandt, MD, guido.hildebrandt@med.uni-rostock.de

    Recruiting

  • Katharinen Hospital Stuttgart

    Stuttgart

    Recruiting

  • University of Tübingen

    Tübingen, 72076

    Stefan Wirths, MD, Stefan.Wirths@med.uni-tuebingen.de

    Recruiting

  • University of Ulm

    Ulm, 89081

    Christian Buske, MD, Christian.buske@uni-ulm.de

    Recruiting

Other trials in Germany

About this study

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.

Being tested
Standard, Experimental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StandardRadiation

    12 x 2 Gy involved site radiotherapy plus Rituximab

  • ExperimentalRadiation

    2 x2 Gy involved site radiotherapy plus Obinutuzumab

  • StandardDrug

    Also called Rituximab

    Rituximab with 12 x 2 Gy involved site radiotherapy

  • ExperimentalDrug

    Also called Obinutuzumab

    Obinutuzumab with 2 x2 Gy involved site radiotherapy

Study groups in NCT05045664
Study groupRoleWhat they receive
StandardActive comparatorStandard dose (24 Gy) involved site radiotherapy plus Rituximab
Receives: Radiation: Standard; Drug: Standard
ExperimentalExperimentalow-dose (4 Gy) involved site radiotherapy in combination with Obinutuzumab
Receives: Radiation: Experimental; Drug: Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphologic complete response

    Rate of morphologic complete response based on CT scan in patients with initially remaining lymphoma

    Measured: Week 18

Secondary outcomes (5)

  1. Metabolic complete response

    Rate of metabolic complete response based on FDG PET in patients with initially remaining lymphoma

    Measured: week 18

  2. Morphologic response

    Morphologic CR in patients with initially remaining lymphoma

    Measured: Month 6

  3. PFS

    Progression-free survival (PFS) of each treatment arm

    Measured: 2 years

  4. Frequency and extent of Toxicity

    Toxicity (NCI-CTC criteria, version 5) of all patients

    Measured: until month 30

  5. Overall survival

    Overall survival (OS) of each treatment arm

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start6 Jul 2022
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Controlled, open, randomised, 2 parallel groups, multi-centre, national, treatment phase III trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05045664
Sponsor's protocol ID
2021-000362-15
Acronym
FORTplus
Status last verified
Apr 2026
First submitted
25 Aug 2021
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31470902

  • 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.

    PubMed 24572077

  • 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.

    PubMed 31723798

  • 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.

    PubMed 33539729

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard and Experimental in people with Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a, run by Heidelberg University at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Klaus Herfarth, MD (+496221568202, klaus.herfarth@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphologic complete response (time frame: Week 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045664, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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