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Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody (FORTplus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05045664
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a Radiation: Standard Radiation: Experimental Drug: Standard Drug: Experimental Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled, open, randomised, 2 parallel groups, multi-centre, national, treatment phase III trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard
Standard dose (24 Gy) involved site radiotherapy plus Rituximab
 Radiation: Standard
12 x 2 Gy involved site radiotherapy plus Rituximab

Drug: Standard
Rituximab with 12 x 2 Gy involved site radiotherapy
Other Name: Rituximab
Experimental: Experimental
ow-dose (4 Gy) involved site radiotherapy in combination with Obinutuzumab
 Radiation: Experimental
2 x2 Gy involved site radiotherapy plus Obinutuzumab

Drug: Experimental
Obinutuzumab with 2 x2 Gy involved site radiotherapy
Other Name: Obinutuzumab


Outcome Measures
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Primary Outcome Measures :
  1. Morphologic complete response [ Time Frame: Week 18 ]
    Rate of morphologic complete response based on CT scan in patients with initially remaining lymphoma


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045664


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

Locations
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Germany
Vivantes Klinikum Berlin Recruiting
Berlin, Germany, 10967
Contact: Christian Scholz, MD       christianw.scholz@vivantes.de   
University of Essen Not yet recruiting
Essen, Germany, 45147
University of Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Stefan Rieken, MD       stefan.rieken@med.uni-goettingen.de   
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Klaus Herfarth, MD    +496221568202    klaus.herfarth@med.uni-heidelberg.de   
Sub-Investigator: Julia Meissner, MD         
LMU München Not yet recruiting
Munich, Germany, 81377
Contact: Martin Dreyling, MD       Martin.dreyling@med.uni-muenchen.de   
Technische Universität München Recruiting
Munich, Germany, 81675
Contact: Simon Heidegger, MD       Simon.heidegger@tum.de   
Strahlentherapie KH Maria Hilf Recruiting
Mönchengladbach, Germany, 41063
Contact: Ursula Nestle, MD    +49-2161-8921801    Ursula.nestle@mariahilf.de   
Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany, 93049
Contact: Bernhard Heilmeier, MD       Bernhard.Heilmeier@barmherzige-regensburg.de   
University of Rostock Recruiting
Rostock, Germany, 18057
Contact: Guido Hildebrandt, MD       guido.hildebrandt@med.uni-rostock.de   
Katharinen Hospital Stuttgart Not yet recruiting
Stuttgart, Germany
University of Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Stefan Wirths, MD       Stefan.Wirths@med.uni-tuebingen.de   
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Christian Buske, MD       Christian.buske@uni-ulm.de   
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Klaus Herfarth, MD Heidelberg University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Klaus Herfarth, MD, Vice Chair, Department of Radiation Oncology, Heidelberg University
ClinicalTrials.gov Identifier: NCT05045664    
Other Study ID Numbers: 2021-000362-15
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents