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NCT Number: NCT05045664

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vivantes Klinikum Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard

Radiation

12 x 2 Gy involved site radiotherapy plus Rituximab

Experimental

Radiation

2 x2 Gy involved site radiotherapy plus Obinutuzumab

Standard

Drug

Rituximab with 12 x 2 Gy involved site radiotherapy

Other names: Rituximab

Experimental

Drug

Obinutuzumab with 2 x2 Gy involved site radiotherapy

Other names: Obinutuzumab

Primary outcomes

  1. Morphologic complete response

    Time frame: Week 18

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

Secondary outcomes

  1. Metabolic complete response

    Time frame: week 18

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

  2. Morphologic response

    Time frame: Month 6

    Morphologic CR in patients with initially remaining lymphoma

  3. PFS

    Time frame: 2 years

    Progression-free survival (PFS) of each treatment arm

  4. Frequency and extent of Toxicity

    Time frame: until month 30

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

  5. Overall survival

    Time frame: 2 years

    Overall survival (OS) of each treatment arm

Study contacts

Contact information is provided by the study sponsor or research team.

Klaus Herfarth, MD

CONTACT

[email protected]

+496221568202

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Acronym: FORTplus

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Sep 16, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.