Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

Last updated: December 3, 2024
Sponsor: Heidelberg University
Overall Status: Active - Recruiting

Phase

3

Condition

Follicular Lymphoma

Lymphoma

Treatment

Experimental

Standard

Standard

Clinical Study ID

NCT05045664
2021-000362-15
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHOclassification (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-PETStaging

  • Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)

  • Written informed consent and willingness to cooperate during the course of thetrial

  • 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 clinicaltrial

  • Adequate contraception for men and women of child-bearing age during therapyand 18 months thereafter

Exclusion

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 constantremission, 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 includingviral hepatitis, uncontrolled concomitant diseases including significantcardiovascular or pulmonary disease

  • Severe psychiatric disease

  • Pregnancy / lactation

  • Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemicalstructure or any other additive of the pharmaceutical formula of the study drug

  • Active hepatitis B infection (inactive hepatitis B infections require additionalprophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)

  • Participation in another interventional trial or follow-up period of a competingtrial which can influence the results of this current trial

  • Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearancenormal), 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

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Experimental
Phase: 3
Study Start date:
July 06, 2022
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Vivantes Klinikum Berlin

    Berlin, 10967
    Germany

    Active - Recruiting

  • University of Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • University of Göttingen

    Göttingen, 37075
    Germany

    Active - Recruiting

  • University Hospital Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • LMU München

    Munich, 81377
    Germany

    Active - Recruiting

  • Technische Universität München

    Munich, 81675
    Germany

    Active - Recruiting

  • Strahlentherapie KH Maria Hilf

    Mönchengladbach, 41063
    Germany

    Active - Recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049
    Germany

    Active - Recruiting

  • University of Rostock

    Rostock, 18057
    Germany

    Active - Recruiting

  • Katharinen Hospital Stuttgart

    Stuttgart,
    Germany

    Active - Recruiting

  • University of Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

  • University of Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

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