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.
Anti-CD20 antibody
Follicular lymphoma
Involved site radiotherapy
Low-dose radiotherapy
Obinutuzumab
PET/CT
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
30 Aug 2019
30 Aug 2019
Historique:
received:
07
12
2018
accepted:
24
07
2019
entrez:
1
9
2019
pubmed:
1
9
2019
medline:
18
2
2020
Statut:
epublish
Résumé
Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irradiation, smaller irradiation fields have been accompanied with an increased risk of out-of-field recurrence. The MIR (MabThera The GAZAI trial is a non-randomized, open, non-controlled, German, multi-center phase II trial that includes patients with early-stage (I and II) nodular FL (grades 1 and 2) confirmed by central histological review. A maximum of 93 patients will be included in the trial. Patients will receive a combined approach of immunotherapy with the fully humanized anti-CD20 antibody obinutuzumab (Gazyvaro The goal of this trial is a further reduction of the radiation dose in patients with nodal early-stage FL showing a good response to a combination of LDRT and anti-CD20 immunotherapy and a comparison with the currently published MIR trial. EudraCT number: 2016-002059-89. ClinicalTrials.gov identifier: NCT03341520 .
Sections du résumé
BACKGROUND
BACKGROUND
Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irradiation, smaller irradiation fields have been accompanied with an increased risk of out-of-field recurrence. The MIR (MabThera
METHODS/DESIGN
METHODS
The GAZAI trial is a non-randomized, open, non-controlled, German, multi-center phase II trial that includes patients with early-stage (I and II) nodular FL (grades 1 and 2) confirmed by central histological review. A maximum of 93 patients will be included in the trial. Patients will receive a combined approach of immunotherapy with the fully humanized anti-CD20 antibody obinutuzumab (Gazyvaro
DISCUSSION
CONCLUSIONS
The goal of this trial is a further reduction of the radiation dose in patients with nodal early-stage FL showing a good response to a combination of LDRT and anti-CD20 immunotherapy and a comparison with the currently published MIR trial.
TRIAL REGISTRATION
BACKGROUND
EudraCT number: 2016-002059-89. ClinicalTrials.gov identifier: NCT03341520 .
Identifiants
pubmed: 31470902
doi: 10.1186/s13063-019-3614-y
pii: 10.1186/s13063-019-3614-y
pmc: PMC6717383
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
obinutuzumab
O43472U9X8
Banques de données
ClinicalTrials.gov
['NCT03341520']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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