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

NCT ID: NCT07256158

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2033-03-01

Brief 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.

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm - 20 Gy Radiotherapy

Involved 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

Group Type: EXPERIMENTAL

20 Gy Involved site radiotherapy

Intervention Type: RADIATION

Total dose 20 Gy Involved site radiotherapy

Comparator arm - 30 Gy Radiotherapy

Involved 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

Group Type: ACTIVE_COMPARATOR

30 Gy Involved site radiotherapy

Intervention Type: RADIATION

Total dose 30 Gy Involved site radiotherapy

Interventions

20 Gy Involved site radiotherapy

Total dose 20 Gy Involved site radiotherapy

Intervention Type: RADIATION

30 Gy Involved site radiotherapy

Total dose 30 Gy Involved site radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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;
• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umberto Ricardi, MD

Role: PRINCIPAL_INVESTIGATOR

SC Radioterapia U - AOU Città della Salute e della Scienza di Torino

Locations

A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia

Alessandria, , Italy

A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate

Avellino, , Italy

IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati

Aviano, , Italy

ASST Papa Giovanni XXIII - S.C. Ematologia

Bergamo, , Italy

Clinica Humanitas Gavazzeni - U.O. Oncologia Medica

Bergamo, , Italy

ASST Spedali Civili - S.C. Ematologia

Brescia, , Italy

ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO

Cagliari, , Italy

I.R.C.C.S. Istituto di Candiolo - FPO

Candiolo, , Italy

ARNAS Garibaldi - U.O.C. Ematologia

Catania, , Italy

A.O. S. Croce e Carle - S.C. Ematologia

Cuneo, , Italy

A.S.L. Toscana Centro - SOC Oncoematologia

Florence, , Italy

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, , Italy

IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari

Genova, , Italy

ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto

Latina, , Italy

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

Milan, , Italy

IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia

Milan, , Italy

A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia

Novara, , Italy

A.O.U. di Padova - U.O.C. Ematologia

Padua, , Italy

I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1

Padua, , Italy

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, , Italy

IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1

Pavia, , Italy

A.O. Ospedale S. Maria della Misericordia - Ematologia

Perugia, , Italy

AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti

Piacenza, , Italy

AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia

Ravenna, , Italy

AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia

Reggio Emilia, , Italy

A.O.U. Policlinico Umberto I - U.O.C Ematologia

Roma, , Italy

A.O.U. Sant'Andrea - U.O.C. Ematologia

Roma, , Italy

Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali

Roma, , Italy

IRCCS Humanitas - U.O. Ematologia

Rozzano, , Italy

IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche

San Giovanni Rotondo, , Italy

A.O.U. Senese - U.O.C. Ematologia

Siena, , Italy

A.O. Santa Maria - S.C. Oncoematologia

Terni, , Italy

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

Torino, , Italy

A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

Torino, , Italy

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

Treviso, , Italy

A.S.U. Giuliano Isontina - S.C. Ematologia

Trieste, , Italy

A.S.U. Friuli Centrale - Clinica Ematologica

Udine, , Italy

A.O.U.I. di Verona - U.O.C. Ematologia

Verona, , Italy

Countries

Italy

Central Contacts

Uffici Studi FIL

Role: CONTACT

startup@filinf.it

+390131033153

Uffici Studi FIL

Role: CONTACT

gestionestudi@filinf.it

+390599769913

Facility Contacts

Manuela Zanni, MD

Role: primary

manuela.zanni@ospedale.al.it

Sonya De Lorenzo, MD

Role: primary

sonya.delorenzo@aornmoscati.it

Michele Spina, MD

Role: primary

mspina@cro.it

Silvia Ferrari, MD

Role: primary

s.ferrari@asst-pg23.it

Daniele Laszlo, MD

Role: primary

daniele.laszlo@gavazzeni.it

Chiara Pagani, MD

Role: primary

chiara.pagani@asst-spedalicivili.it

Valeria Oggianu, MD

Role: primary

valeria.oggianu@aob.it

Umberto Vitolo, MD

Role: primary

umberto.vitolo@ircc.it

Ugo Consoli, MD

Role: primary

uconsoli@arnasgaribaldi.it

Roberto Sorasio, MD

Role: primary

sorasio.r@ospedale.cuneo.it

Sabrina Moretti, MD

Role: primary

sabrina.moretti@uslcentro.toscana.it

Benedetta Puccini, MD

Role: primary

puccinib@aou-careggi.toscana.it

Chiara Ghiggi, MD

Role: primary

chiara.ghiggi@hsanmartino.it

Natalia Cenfra, MD

Role: primary

nataliacenfra81@gmail.com

Vittorio Riggero Zilioli, MD

Role: primary

vittorioruggero.zilioli@ospedaleniguarda.it

Paolo Corradini, MD

Role: primary

paolo.corradini@unimi.it

Riccardo Bruna, MD

Role: primary

riccardo.bruna@maggioreosp.novara.it

Andrea Visentin, MD

Role: primary

andrea.visentin@aopd.veneto.it

Dario Marino, MD

Role: primary

dario.marino@iov.veneto.it

Caterina Patti, MD

Role: primary

k.patti@villasofia.it

Manuel Gotti, MD

Role: primary

ma.gotti@smatteo.pv.it

Leonardo Flenghi, MD

Role: primary

leonardo.flenghi@ospedale.perugia.it

Annalisa Arcari, MD

Role: primary

a.arcari@ausl.pc.it

Monica Tani, MD

Role: primary

monica.tani@auslromagna.it

Angela Ferrari, MD

Role: primary

ferrari.angela@ausl.re.it

Ilaria Del Giudice, MD

Role: primary

ilaria.delgiudice@uniroma1.it

Giacinto La Verde, MD

Role: primary

glaverde@ospedalesantandrea.it

Luigi Rigacci, MD

Role: primary

l.rigacci@policlinicocampus.it

Francesca Ricci, MD

Role: primary

francesca.ricci@humanitas.it

Angelo Michele Carella, MD

Role: primary

am.carella@operapadrepio.it

Alberto Fabbri, MD

Role: primary

fabbri7@unisi.it

Arcangelo Liso, MD

Role: primary

arcangelo.liso@unipg.it

Candida Vitale, MD

Role: primary

candida.vitale@unito.it

Barbara Botto, MD

Role: primary

bbotto@cittadellasalute.to.it

Piero Maria Stefani, MD

Role: primary

pieromaria.stefani@aulss2.veneto.it

Francesco Zaja, MD

Role: primary

francesco.zaja@asugi.sanita.fvg.it

Jacopo Olivieri, MD

Role: primary

jacopo.olivieri@asufc.sanita.fvg.it

Andrea Bernardelli, MD

Role: primary

andrea.bernardelli@aovr.veneto.it

Other Identifiers

FIL_PRIORITY

Identifier Type: -

Identifier Source: org_study_id