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Clinical Trials in Italy / NCT07256158
Recruiting Phase 3

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

NCT07256158 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2026-07-10
Last updated
2026-08-27

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

20 Gy Involved site radiotherapy30 Gy Involved site radiotherapy

20 Gy Involved site radiotherapy: Total dose 20 Gy Involved site radiotherapy

30 Gy Involved site radiotherapy: Total dose 30 Gy Involved site radiotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia Alessandria Italy Not Yet Recruiting
A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate Avellino Italy Not Yet Recruiting
IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati Aviano Italy Not Yet Recruiting
ASST Papa Giovanni XXIII - S.C. Ematologia Bergamo Italy Not Yet Recruiting
Clinica Humanitas Gavazzeni - U.O. Oncologia Medica Bergamo Italy Not Yet Recruiting
ASST Spedali Civili - S.C. Ematologia Brescia Italy Not Yet Recruiting
ARNAS "Brotzu" P.O. Businco - S.C. Ematologia e TMO Cagliari Italy Not Yet Recruiting
I.R.C.C.S. Istituto di Candiolo - FPO Candiolo Italy Not Yet Recruiting
ARNAS Garibaldi - U.O.C. Ematologia Catania Italy Not Yet Recruiting
A.O. S. Croce e Carle - S.C. Ematologia Cuneo Italy Not Yet Recruiting
A.S.L. Toscana Centro - SOC Oncoematologia Florence Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia Florence Italy Not Yet Recruiting
IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari Genova Italy Not Yet Recruiting
ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto Latina Italy Not Yet Recruiting
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia Milan Italy Not Yet Recruiting
IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia Milan Italy Not Yet Recruiting
A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia Novara Italy Not Yet Recruiting
A.O.U. di Padova - U.O.C. Ematologia Padova Italy Not Yet Recruiting
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 Padova Italy Not Yet Recruiting
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia Palermo Italy Not Yet Recruiting
IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1 Pavia Italy Not Yet Recruiting
A.O. Ospedale S. Maria della Misericordia - Ematologia Perugia Italy Not Yet Recruiting
AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti Piacenza Italy Not Yet Recruiting
AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia Ravenna Italy Not Yet Recruiting
AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia Reggio Emilia Italy Not Yet Recruiting
A.O.U. Policlinico Umberto I - U.O.C Ematologia Roma Italy Not Yet Recruiting
A.O.U. Sant'Andrea - U.O.C. Ematologia Roma Italy Not Yet Recruiting
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali Roma Italy Not Yet Recruiting
IRCCS Humanitas - U.O. Ematologia Rozzano Italy Not Yet Recruiting
IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche San Giovanni Rotondo Italy Not Yet Recruiting
A.O.U. Senese - U.O.C. Ematologia Siena Italy Not Yet Recruiting
A.O. Santa Maria - S.C. Oncoematologia Terni Italy Not Yet Recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U Torino Italy Not Yet Recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia Torino Italy Recruiting
ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia Treviso Italy Not Yet Recruiting
A.S.U. Giuliano Isontina - S.C. Ematologia Trieste Italy Not Yet Recruiting
A.S.U. Friuli Centrale - Clinica Ematologica Udine Italy Not Yet Recruiting
A.O.U.I. di Verona - U.O.C. Ematologia Verona Italy Not Yet Recruiting

More Fondazione Italiana Linfomi - ETS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07256158 on ClinicalTrials.gov ↗ ← All trials in Italy