Prospective, multicenter, non-interventional, biological study ancillary to FIL-Rouge clinical trial (NCT03159897) enrolling patients affected by Advanced-stage Hodgkin Lymphoma, ABVD-based upfront treatment in 19 centers in Italy part of Fondazione Italiana Linfomi.
The FIL-Rouge design provides an ideal environment for validating the liquid biopsy in Classical Hodgkin lymphoma (cHL), since one arm of the study will utilize a PET/CT-adapted strategy (Positron Emission Tomography/Computed Tomography)for treatment, while the second arm will be devoid of any PET/CT-adaptation of therapy. Also, estimating prospectively differences in residual disease between the two study arms of the FIL-Rouge will provide an important biologic tool to validate the concept of dose-intensification within the ABVD therapeutic platform. This study aims at the prospective validation of the concept of the liquid biopsy as a biomarker for disease response assessment in cHL. The patients enrolled in the FIL-Rouge clinical trial at the centers participating in this study and consenting to the biological study FIL-RougeBIO will be considered for this study. After providing written informed consent, relevant patients will be evaluated for detecting cancer gene mutations in ctDNA (Circulating Tumor DNA) for measuring residual disease. All clinical data useful for data analyses of this study will derive from the FIL-Rouge clinical trial. Given the non-interventional design of the study, project participants will not have immediate potential benefits.The enrollment in FIL-RougeBIO will parallel the original protocol until reaching the 500 programmed patients. The results of this study could benefit future patients with the same condition.
Study Type
OBSERVATIONAL
Enrollment
100
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Bari, Italy
ASST Spedali Civili di Brescia - Ematologia
Complete Response Rate (CRR)
Complete Response Rate (CRR) is defined as the proportion of patients achieving a Complete Remission (CR) at the end of treatment;
Time frame: The endpoint will be assessed from the beginning of the study up to 76 months
Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (Positron Emission Tomography/Computed Tomography)
Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios accuracy); The endpoint will be evaluated through specific timepoints.
Time frame: The endpoint will be assessed from the beginning of the study up to 76 months
Progression Free Survival (PFS) with at least three years of follow up
PFS is defined as the interval elapsing from randomization until lymphoma progression/relapse or death as a result of any cause.
Time frame: The endpoint will be assessed from the beginning of the study up to 76 months
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Brescia, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica
Napoli, Italy
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, Italy
Ospedale S. Maria della Misericordia - Ematologia
Perugia, Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
...and 3 more locations