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AzTrials

Hodgkin LymphomaPhase 3FIL_PRIORITYNCT07256158

PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma

A Phase 3 study testing 20 Gy Involved site radiotherapy and 30 Gy Involved site radiotherapy in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 38 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The final analysis of GHSG HD11 study (not PET driven) showed that 30 Gy IFRT still remains the standard dose after 4 ABVD. Early PET negativity might allow safe radiation de-escalation in patients achieving a metabolic complete response after 2 ABVD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
20 Gy Involved site radiotherapy and 30 Gy Involved site radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
38 sitesItaly
Study dates
10 Jul 2026to Aug 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years;
  • Histologically confirmed classical HL stage I, II unfavorable according to GHSG criteria;
  • Patient with any nodal mass ≥ than 10 cm can be included
  • No previous treatment for Hodgkin lymphoma;
  • ECOG performance status 0 to 2;
  • Presence of FDG-avid lymphoma lesions on baseline PET scan;
Show all 16Show fewer
  • Subject understands and voluntarily signs the informed consent form approved by the Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures;
  • Adequate organ and marrow function as defined below:
  • absolute neutrophil count > 1.0 x109/L
  • platelet count > 75 x109/L
  • Total bilirubin < 2 mg/dl without a pattern consistent with Gilbert's syndrome
  • Aspartate Transaminase and Alanine Transaminase (AST/ALT) < 3.0 X institutional Upper Limits of Normality (ULN)
  • Creatinine within normal institutional limits or creatinine clearance > 50 mL/min
  • Women of childbearing potential must agree to use a highly effective method of contraception (oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) from the signature of informed consent until six months after the last dose of treatment;
  • Men must agree to use a highly effective method of contraception (barrier contraception or abstinence, when this is in line with the usual lifestyle of the subject) from the signature of informed consent until six months after the last dose of treatment;
  • Women of childbearing potential must have a negative serum pregnancy test at screening.

Who cannot join

  • Patients who meet any of the following criteria are not eligible to enroll:
  • Stage II B- III- IV
  • Hodgkin Lymphoma as "composite lymphoma" or nodular lymphocyte prevalence histological subtype
  • Active HBV and HCV infection
  • HIV seropositivity
  • Pre-treatment with chemotherapy or radiation therapy
Show all 10Show fewer
  • Malignant disease within the last 5 years (excluding basal skin tumors and carcinoma in situ of the cervix)
  • Women who are pregnant or breast feeding
  • Absence of FDG-avid lymphoma lesions on baseline PET scan
  • Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.

Trial locations and contacts

38 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Uffici Studi FIL contact

+390131033153

startup@filinf.it

Uffici Studi FIL contact

+390599769913

gestionestudi@filinf.it

38 sites in 1 country

Italy38 sites, 38 recruiting
  • A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia

    Alessandria

    Manuela Zanni, MD, manuela.zanni@ospedale.al.it

    Manuela Zanni, MD

    Not yet recruiting
  • A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate

    Avellino

    Sonya De Lorenzo, MD, sonya.delorenzo@aornmoscati.it

    Sonya De Lorenzo, MD

    Not yet recruiting
  • IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati

    Aviano

    Michele Spina, MD, mspina@cro.it

    Michele Spina, MD

    Not yet recruiting
  • ASST Papa Giovanni XXIII - S.C. Ematologia

    Bergamo

    Silvia Ferrari, MD, s.ferrari@asst-pg23.it

    Silvia Ferrari, MD

    Not yet recruiting
  • Clinica Humanitas Gavazzeni - U.O. Oncologia Medica

    Bergamo

    Daniele Laszlo, MD, daniele.laszlo@gavazzeni.it

    Daniele Laszlo, MD

    Not yet recruiting
  • ASST Spedali Civili - S.C. Ematologia

    Brescia

    Chiara Pagani, MD, chiara.pagani@asst-spedalicivili.it

    Chiara Pagani, MD

    Not yet recruiting
  • ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO

    Cagliari

    Valeria Oggianu, MD, valeria.oggianu@aob.it

    Valeria Oggianu, MD

    Not yet recruiting
  • I.R.C.C.S. Istituto di Candiolo - FPO

    Candiolo

    Umberto Vitolo, MD, umberto.vitolo@ircc.it

    Umberto Vitolo, MD

    Not yet recruiting
  • ARNAS Garibaldi - U.O.C. Ematologia

    Catania

    Ugo Consoli, MD, uconsoli@arnasgaribaldi.it

    Ugo Consoli, MD

    Not yet recruiting
  • A.O. S. Croce e Carle - S.C. Ematologia

    Cuneo

    Roberto Sorasio, MD, sorasio.r@ospedale.cuneo.it

    Roberto Sorasio, MD

    Not yet recruiting
  • A.S.L. Toscana Centro - SOC Oncoematologia

    Florence

    Sabrina Moretti, MD, sabrina.moretti@uslcentro.toscana.it

    Sabrina Moretti, MD

    Not yet recruiting
  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence

    Benedetta Puccini, MD, puccinib@aou-careggi.toscana.it

    Benedetta Puccini, MD

    Not yet recruiting
  • IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari

    Genova

    Chiara Ghiggi, MD, chiara.ghiggi@hsanmartino.it

    Chiara Ghiggi, MD

    Not yet recruiting
  • ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto

    Latina

    Natalia Cenfra, MD, nataliacenfra81@gmail.com

    Natalia Cenfra, MD

    Not yet recruiting
  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

    Milan

    Vittorio Riggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it

    Vittorio Ruggero Zilioli, MD

    Not yet recruiting
  • IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia

    Milan

    Paolo Corradini, MD, paolo.corradini@unimi.it

    Paolo Corradini, MD

    Not yet recruiting
  • A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia

    Novara

    Riccardo Bruna, MD, riccardo.bruna@maggioreosp.novara.it

    Riccardo Bruna, MD

    Not yet recruiting
  • A.O.U. di Padova - U.O.C. Ematologia

    Padova

    Andrea Visentin, MD, andrea.visentin@aopd.veneto.it

    Andrea Visentin, MD

    Not yet recruiting
  • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1

    Padova

    Dario Marino, MD, dario.marino@iov.veneto.it

    Dario Marino, MD

    Not yet recruiting
  • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

    Palermo

    Caterina Patti, MD, k.patti@villasofia.it

    Caterina Patti, MD

    Not yet recruiting
  • IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1

    Pavia

    Manuel Gotti, MD, ma.gotti@smatteo.pv.it

    Manuel Gotti, MD

    Not yet recruiting
  • A.O. Ospedale S. Maria della Misericordia - Ematologia

    Perugia

    Leonardo Flenghi, MD, leonardo.flenghi@ospedale.perugia.it

    Leonardo Flenghi, MD

    Not yet recruiting
  • AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti

    Piacenza

    Annalisa Arcari, MD, a.arcari@ausl.pc.it

    Annalisa Arcari, MD

    Not yet recruiting
  • AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia

    Ravenna

    Monica Tani, MD, monica.tani@auslromagna.it

    Monica Tani, MD

    Not yet recruiting
  • AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia

    Reggio Emilia

    Angela Ferrari, MD, ferrari.angela@ausl.re.it

    Angela Ferrari, MD

    Not yet recruiting
  • A.O.U. Policlinico Umberto I - U.O.C Ematologia

    Roma

    Ilaria Del Giudice, MD, ilaria.delgiudice@uniroma1.it

    Ilaria Del Giudice, MD

    Not yet recruiting
  • A.O.U. Sant'Andrea - U.O.C. Ematologia

    Roma

    Giacinto La Verde, MD, glaverde@ospedalesantandrea.it

    Giacinto La Verde, MD

    Not yet recruiting
  • Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali

    Roma

    Luigi Rigacci, MD, l.rigacci@policlinicocampus.it

    Luigi Rigacci, MD

    Not yet recruiting
  • IRCCS Humanitas - U.O. Ematologia

    Rozzano

    Francesca Ricci, MD, francesca.ricci@humanitas.it

    Francesca Ricci, MD

    Not yet recruiting
  • IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche

    San Giovanni Rotondo

    Angelo Michele Carella, MD, am.carella@operapadrepio.it

    Angelo Michele Carella, MD

    Not yet recruiting
  • A.O.U. Senese - U.O.C. Ematologia

    Siena

    Alberto Fabbri, MD, fabbri7@unisi.it

    Alberto Fabbri, MD

    Not yet recruiting
  • A.O. Santa Maria - S.C. Oncoematologia

    Terni

    Arcangelo Liso, MD, arcangelo.liso@unipg.it

    Arcangelo Liso, MD

    Not yet recruiting
  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

    Torino

    Candida Vitale, MD, candida.vitale@unito.it

    Candida Vitale, MD

    Not yet recruiting
  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

    Torino

    Barbara Botto, MD, bbotto@cittadellasalute.to.it

    Barbara Botto, MD

    Recruiting
  • ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia

    Treviso

    Piero Maria Stefani, MD, pieromaria.stefani@aulss2.veneto.it

    Piero Maria Stefani, MD

    Not yet recruiting
  • A.S.U. Giuliano Isontina - S.C. Ematologia

    Trieste

    Francesco Zaja, MD, francesco.zaja@asugi.sanita.fvg.it

    Francesco Zaja, MD

    Not yet recruiting
  • A.S.U. Friuli Centrale - Clinica Ematologica

    Udine

    Jacopo Olivieri, MD, jacopo.olivieri@asufc.sanita.fvg.it

    Jacopo Olivieri, MD

    Not yet recruiting
  • A.O.U.I. di Verona - U.O.C. Ematologia

    Verona

    Andrea Bernardelli, MD, andrea.bernardelli@aovr.veneto.it

    Andrea Bernardelli, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma: a Randomized, Phase III, Non-inferiority studY (PRIORITY Study)

The final analysis of GHSG HD11 study (not PET driven) showed that 30 Gy IFRT still remains the standard dose after 4 ABVD.

Early PET negativity might allow safe radiation de-escalation in patients achieving a metabolic complete response after 2 ABVD.

The aim of Priority trial is to explore whether radiotherapy could be safely deescalated to 20 Gy without loss of efficacy in patients treated with four cycles of ABVD who achieved complete metabolic response after the first two cycles.

Being tested
20 Gy Involved site radiotherapy, 30 Gy Involved site radiotherapy
Keywords
Hodgkin lymphoma, Early stage, unfavourable, untreated, ABVD, chemotherapy, radiotherapy, 20 Gy, 30 Gy, randomization, PET guided, involved site
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 Gy Involved site radiotherapyRadiation

    Total dose 20 Gy Involved site radiotherapy

  • 30 Gy Involved site radiotherapyRadiation

    Total dose 30 Gy Involved site radiotherapy

Study groups in NCT07256158
Study groupRoleWhat they receive
Experimental arm - 20 Gy RadiotherapyExperimentalInvolved site radiotherapy (ISRT) Total dose of 20 Gy is administered in 10 daily fractions of 2.0 Gy, five times a week over 2 weeks
Receives: Radiation: 20 Gy Involved site radiotherapy
Comparator arm - 30 Gy RadiotherapyActive comparatorInvolved site radiotherapy (ISRT) Total dose of 30 Gy is administered in 15 daily fractions of 2.0 Gy, five times a week over 3 weeks
Receives: Radiation: 30 Gy Involved site radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate if de-escalated ISRT dose (20 Gy) is not inferior to conventional ISRT dose (30 Gy) in terms of PFS in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycle

    Progression-Free Survival (PFS) of the randomized population. Subjects with incomplete follow-up or with no disease evaluation will be censored at the date of last available documented status of freedom from failure.

    Measured: From the date of randomization to documented relapse, progression or to the patient's death as a result of any causes (up to 82 months).

Secondary outcomes (5)
  1. To compare OS rates between de-escalated ISRT dose (20 Gy) and conventional ISRT dose (30 Gy) in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycles;

    Overall Survival (OS) for the randomized population

    Measured: From the time of randomization to death from any cause (up to 82 months)

  2. To evaluate PFS for the whole population

    Progression free survival for the whole enrolled population

    Measured: From the date of consent to documented relapse, progression or death from any cause (up to 84 months)

  3. To evaluate OS for the whole population

    Overall Survival (OS) for the whole population

    Measured: From the date of consent to death from any cause (up to 84 months)

  4. To describe pattern of failure "in field", "marginal field", "out of field" relapse after conventional and reduced ISRT;

    Incidence and severity of Adverse Events, graded according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE v 5.0) during the treatment

    Measured: From the date of consent to death from any cause (up to 84 months)

  5. To report details on RT treatment volumes and dose distributions and to estimate the dose received by the organs at risk (OARs) in the two treatment arms

    RT dose received by organs at risk (OARs).

    Measured: At time of radiotherapy (about 4 months from chemotherapy start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start10 Jul 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionAug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Phase III, Non-inferiority study
Masking
None (open label)
Enrolment
518 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256158
Sponsor's protocol ID
FIL_PRIORITY
Acronym
FIL_PRIORITY
Status last verified
Aug 2026
First submitted
20 Nov 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20 Gy Involved site radiotherapy and 30 Gy Involved site radiotherapy in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 38 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 10 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate if de-escalated ISRT dose (20 Gy) is not inferior to conventional ISRT dose (30 Gy) in terms of PFS in patients with newly diagnosed early-stage unfavourable HL achieving a complete metabolic response (DS 1-3) after 2 ABVD cycle (time frame: From the date of randomization to documented relapse, progression or to the patient's death as a result of any causes (up to 82 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 27 Aug 2026.

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