Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EZH2 mutations/CNAs by droplet digital PCR (ddPCR), EZH2-derived gene expression signature by RNA-Seq.
- Кому может быть актуально
- Состояния в реестре: Follicular Lymphoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated.
Подробное описание
Current standard first-line treatment for advanced follicular lymphoma (FL) is still represented by chemoimmunotherapy combinations, with CHOP/CVP or bendamustine (B) as the main regimens with no standard criteria to prefer one over another.
EZH2 mutations have been associated with longer progression-free survival (PFS) in patients treated with CHOP/CVP regimens, but not with Bendamustine (independently from the type of anti-CD20 therapy received).
The FIL\_FOLL12 trial (NCT02063685), a large phase III trial (with a pre-planned biological material sampling) enrolling 807 advanced FL patients treated with front-line R-CHOP or bendamustine-rituximab (BR), appears an ideal platform to validate the predictive value of EZH2 and its applicability to the clinical practice.
The aim of this study is to provide to clinicians a useful and practical biomarker to guide the choice of the most effective chemotherapy backbone (in addition to anti-CD20 immunotherapy) for first line treatment of patients with advanced FL (e.g. R-CHOP for EZH2 aberrated vs BR for EZH2 wild type patients).
Moreover, to implement an Italian network of laboratories able to provide these translational outputs within a rapid turnaround time.
Finally, taking advantage of the already collected BM and PB samples, several novel biomarkers of FL heterogeneity will be investigated, in particular: EZH2 protein expression in tumor samples, alternative molecular markers for minimal residual disease (MRD), clonal hematopoiesis of indeterminate potential (CHIP), pharmacogenomics and constitutional genomics as well as microbiome profiles.
Вмешательства
- Диагностический тест EZH2 mutations/CNAs by droplet digital PCR (ddPCR)
Test of EZH2 mutations/CNAs by droplet digital PCR (ddPCR) in peripheral blood and in unsorted bone marrow aspirate samples at enrolment - Диагностический тест EZH2-derived gene expression signature by RNA-Seq
Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples
Первичные конечные точки
- Progression free survival [Срок оценки: From treatment start up to 43 months]
Вторичные конечные точки (2)
- Response rate [Срок оценки: From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)]
- Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature [Срок оценки: Before treatment start]
Критерии участия
Критерии включения
- Patient enrolled in the FIL\_FOLL12 trial (documented by the signature of the study informed consent);
- Availability of biological samples: bone marrow aspirate, peripheral blood and/or FFPE diagnostic sample (nodal or extranodal);
Критерии исключения
- None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 26 центров
- A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia — Alessandria
- Nuovo Ospedale degli Infermi, SSD Ematologia — Biella
- ASST Spedali Civili di Brescia - Ematologia — Brescia
- Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia — Catania
- A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo — Cuneo
- Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence
- Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie ce — Genova
- IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia — Meldola
- … и ещё 18 центров
Идентификаторы
NCT: NCT05816850 · FIL_FOLL-BIO