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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia
NOT_YET_RECRUITING
Alessandria
A.O.R.N. G Moscati - U.O.C. Ematologia e Terapie cellulari avanzate
NOT_YET_RECRUITING
Avellino
IRCCS Centro Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
NOT_YET_RECRUITING
Aviano
ASST Papa Giovanni XXIII - S.C. Ematologia
NOT_YET_RECRUITING
Bergamo
Clinica Humanitas Gavazzeni - U.O. Oncologia Medica
NOT_YET_RECRUITING
Bergamo
ASST Spedali Civili - S.C. Ematologia
NOT_YET_RECRUITING
Brescia
ARNAS Brotzu P.O. Businco - S.C. Ematologia e TMO
NOT_YET_RECRUITING
Cagliari
I.R.C.C.S. Istituto di Candiolo - FPO
NOT_YET_RECRUITING
Candiolo
ARNAS Garibaldi - U.O.C. Ematologia
NOT_YET_RECRUITING
Catania
A.O. S. Croce e Carle - S.C. Ematologia
NOT_YET_RECRUITING
Cuneo
A.S.L. Toscana Centro - SOC Oncoematologia
NOT_YET_RECRUITING
Florence
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
NOT_YET_RECRUITING
Florence
IRCCS Policlinico S. Martino - U.O. Ematologia e terapie cellulari
NOT_YET_RECRUITING
Genova
ASL Latina Ospedale S. Maria Goretti - UOC Ematologia con trapianto
NOT_YET_RECRUITING
Latina
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
NOT_YET_RECRUITING
Milan
IRCCS Fondazione Istituto Nazionale Tumori - S.C. Ematologia
NOT_YET_RECRUITING
Milan
A.O.U. Ospedale Maggiore della Carità - S.C.D.U. Ematologia
NOT_YET_RECRUITING
Novara
A.O.U. di Padova - U.O.C. Ematologia
NOT_YET_RECRUITING
Padova
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
NOT_YET_RECRUITING
Padova
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
NOT_YET_RECRUITING
Palermo
IRCCS Fondazione Policlinico S. Matteo - S.C. Ematologia 1
NOT_YET_RECRUITING
Pavia
A.O. Ospedale S. Maria della Misericordia - Ematologia
NOT_YET_RECRUITING
Perugia
AUSL di Piacenza Ospedale Guglielmo da Saliceto - U.O.C. Ematologia e centro trapianti
NOT_YET_RECRUITING
Piacenza
AUSL di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
NOT_YET_RECRUITING
Ravenna
AUSL IRCCS Arcispedale S. Maria Nuova - S.C. Ematologia
NOT_YET_RECRUITING
Reggio Emilia
A.O.U. Policlinico Umberto I - U.O.C Ematologia
NOT_YET_RECRUITING
Roma
A.O.U. Sant'Andrea - U.O.C. Ematologia
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
NOT_YET_RECRUITING
Roma
IRCCS Humanitas - U.O. Ematologia
NOT_YET_RECRUITING
Rozzano
IRCCS Fondazione Casa Sollievo della Sofferenza - UOC Ematologia e Trapianto di Cellule Staminali Ematopoietiche
NOT_YET_RECRUITING
San Giovanni Rotondo
A.O.U. Senese - U.O.C. Ematologia
NOT_YET_RECRUITING
Siena
A.O. Santa Maria - S.C. Oncoematologia
NOT_YET_RECRUITING
Terni
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
RECRUITING
Torino
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
NOT_YET_RECRUITING
Torino
ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia
NOT_YET_RECRUITING
Treviso
A.S.U. Giuliano Isontina - S.C. Ematologia
NOT_YET_RECRUITING
Trieste
A.S.U. Friuli Centrale - Clinica Ematologica
NOT_YET_RECRUITING
Udine
A.O.U.I. di Verona - U.O.C. Ematologia
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Uffici Studi FIL
startup@filinf.it
+390131033153
Backup
Uffici Studi FIL
gestionestudi@filinf.it
+390599769913
Time Frame
Start Date: 2026-07-10
Estimated Completion Date: 2033-08
Participants
Target number of participants: 518
Treatments
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Fondazione Italiana Linfomi - ETS

This content was sourced from clinicaltrials.gov