Hodgkin LymphomaFIL-RougeBIONCT05066555
Circulating Tumor DNA Genotyping for Biological Monitoring of Patients Treated in the FIL-Rouge Clinical Trial
An observational study of Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 13 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 100 participants
- Where
- 13 sitesItaly
- Study dates
- 8 Apr 2020to 3 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eligibility criteria for participation in this study require: * Enrollment in the FIL-Rouge clinical trial; * Evidence of signed informed consent for the biological FIL-RougeBIO study.
Who may be able to join
- Histologically confirmed classical HL
- 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
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- 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
Who cannot join
- Nodular Lymphocyte Predominant HL
- 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)
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Bari
ASST Spedali Civili di Brescia - Ematologia
Brescia
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica
Naples
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia
Ospedale S. Maria della Misericordia - Ematologia
Perugia
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia
Torino
About this study
Official title: Circulating Tumor DNA Genotyping for Biological Monitoring of Patients with Advanced-stage Classical HL Receiving Upfront ABVD-based Chemotherapy. an Ancillary Study to the FIL-Rouge Phase III Trial
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.
Read the detailed description
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.
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, ABVD treatment, ancillary, ctDNA, cHL, FIL-Rouge, PFS, Response Rate
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: The endpoint will be assessed from the beginning of the study up to 76 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: The endpoint will be assessed from the beginning of the study up to 76 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start8 Apr 2020
- Primary completion2 Nov 2021
- Study completion3 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Pinto, MD, Principal investigator, Dipartimento di Ematologia, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS, Napoli, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066555
- Sponsor's protocol ID
- FIL-RougeBIO
- Acronym
- FIL-RougeBIO
- Status last verified
- Dec 2024
- First submitted
- 6 Sep 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Genotyping for Biological Monitoring of Patients with Advanced-stage Classical HL Receiving Upfront ABVD-based Chemotherapy. an Ancillary Study to the FIL-Rouge Phase III Trial
- ClinicalTrials.gov ID
- NCT05066555
- Acronym / sponsor ID
- FIL-RougeBIO / FIL-RougeBIO
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, ABVD treatment, ancillary, ctDNA, cHL, FIL-Rouge, PFS, Response Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligibility criteria for participation in this study require: * Enrollment in the FIL-Rouge clinical trial; * Evidence of signed informed consent for the biological FIL-RougeBIO study.
Key inclusion criteria (16 listed)
- Histologically confirmed classical HL
- 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
Key exclusion criteria (14 listed)
- Nodular Lymphocyte Predominant HL
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete Response Rate (CRR)
Time frame: The endpoint will be assessed from the beginning of the study up to 76 months
Complete Response Rate (CRR) is defined as the proportion of patients achieving a Complete Remission (CR) at the end of treatment;
2 secondary outcomes
Diagnostic accuracy of Circulating tumor DNA (ctDNA) analysis versus interim PET/CT (Positron Emission Tomography/Computed Tomography)
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
Time frame: The endpoint will be assessed from the beginning of the study up to 76 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Pinto, MD principal investigator
Dipartimento di Ematologia, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS, Napoli, Italy
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: The endpoint will be assessed from the beginning of the study up to 76 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.