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JOURNAL ONKOLOGIE – STUDIE
FORTplus

Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody

Rekrutierend

NCT-Nummer:
NCT05045664

Studienbeginn:
Juli 2022

Letztes Update:
13.03.2023

Wirkstoff:
Standard, Experimental

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Heidelberg University

Collaborator:
-

Studienleiter

Klaus Herfarth, MD
Principal Investigator
Heidelberg University

Kontakt

Studienlocations
(3 von 12)

University of Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
University Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Klaus Herfarth, MD
Phone: +496221568202
E-Mail: klaus.herfarth@med.uni-heidelberg.de» Ansprechpartner anzeigen
Gynäkologisches Krebszentrum am Klinikum der LMU München
Marchioninistraße 15
81377 München
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Martin Dreyling, MD
E-Mail: Martin.dreyling@med.uni-muenchen.de» Ansprechpartner anzeigen
Strahlentherapie KH Maria Hilf
41063 Mönchengladbach
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ursula Nestle, MD
Phone: +49-2161-8921801
E-Mail: Ursula.nestle@mariahilf.de» Ansprechpartner anzeigen
Onkologisches Zentrum - Krankenhaus Barmherzige Brüder Regensburg
Prüfeninger Straße 86
93049 Regensburg
(Bayern)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Bernhard Heilmeier, MD
E-Mail: Bernhard.Heilmeier@barmherzige-regensburg.de» Ansprechpartner anzeigen
Katharinen Hospital Stuttgart
Stuttgart
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

  • Active Comparator: Standard
    Standard dose (24 Gy) involved site radiotherapy plus Rituximab
  • Experimental: Experimental
    ow-dose (4 Gy) involved site radiotherapy in combination with Obinutuzumab

Geprüfte Regime

  • Standard:
    12 x 2 Gy involved site radiotherapy plus Rituximab
  • Experimental:
    2 x2 Gy involved site radiotherapy plus Obinutuzumab
  • Standard (Rituximab):
    Rituximab with 12 x 2 Gy involved site radiotherapy
  • Experimental (Obinutuzumab):
    Obinutuzumab with 2 x2 Gy involved site radiotherapy

Quelle: ClinicalTrials.gov


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