Circulating Tumor DNA Genotyping for Biological Monitoring of Patients Treated in the FIL-Rouge Clinical Trial
NCT ID: NCT05066555
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2020-04-08
2024-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Advanced-stage Hodgkin Lymphoma patients (1)
All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Comparator arm).
No interventions assigned to this group
Advanced-stage Hodgkin Lymphoma patients (2)
All patients will be accrued by investigators from the 19 best recruiting centers in the FIL-Rouge clinical trial. Patients had undergone to ABVD-based upfront treatment in FIL-Rouge trial (Experimental arm).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Previously untreated disease
* Age 18-60 years
* Ann Arbor stage IIB with extranodal involvement and/or bulk, III and IV
* At least one target PET-avid bidimensionally assessable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
* Adequate organ and marrow function as defined below:
* Absolute neutrophil count \>1,0 x109/L, platelets \>75 x109/L
* Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome
* Aspartate Transaminase and Alanine Transaminase (AST/ALT) \<3 X institutional Upper Limits of Normality (ULN)
* Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2
* Females of childbearing must have a negative pregnancy test under medical supervision even if patients had been using effective contraception
* Life expectancy \> 6 months
* Able to adhere to the study visit schedule and other protocol requirements
* Signed (or legally acceptable representatives must sign) informed consent indicating that patients understand the purpose of and procedures required for the study and are willing to participate in the study.
* Access to PET-CT (Positron Emission Tomography/Computed Tomography) scans facilities qualified by FIL
Exclusion Criteria
* Ann Arbor stage IIB without extranodal involvement and/or mediastinal bulky
* Prior chemotherapy or radiation therapy
* Pregnant or lactating females
* Known hypertension, cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
* Abnormal QTc interval prolonged (\>450 msec in males; \>470 msec in women)
* Diffusion lung capacity for CO (DLCO)and/or Forced expiratory volume in the 1st second (FEV1) tests \<50% of predicted not due to mediastinal compression or parenchymal lymphoma
* Known cerebral or meningeal disease (HL or any other etiology)
* Prior history of malignancies unless the patient has been free of the disease for five years. Exceptions include the following: basal cells carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast and prostate cancer with the TNM stage of T1a or T1b
* Uncontrolled infectious disease
* Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (Hepatitis B core) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided (Lamivudine)
* Uncompensated diabetes
* Refusal of adequate contraception
* Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
18 Years
60 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Antonio Pinto, MD
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Ematologia, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS, Napoli, Italy
Locations
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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
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
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, , Italy
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia
Torino, , Italy
Countries
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Other Identifiers
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FIL-RougeBIO
Identifier Type: -
Identifier Source: org_study_id