PET-Guided Dose Reduction for Involved-Site Radiotherapy in Early Unfavourable Hodgkin Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial investigates de-escalating involved-site radiotherapy from 30 Gy to 20 Gy in patients with early-stage unfavourable classical Hodgkin lymphoma who achieve PET-based metabolic complete response after two cycles of ABVD, following four total cycles. Participants must have FDG-avid disease, be 18 years or older, and meet specific organ function and performance status criteria. The study compares the safety and efficacy of the reduced radiation dose to the standard dose to determine if disease control is maintained. The design reflects a precision-medicine approach by using PET response to guide treatment intensity. Enrollment is limited to sites in Italy under the Fondazione Italiana Linfomi network.

Why it matters

Who can join: the full rules

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.

Where it's running

• A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
  Torino, Italy Recruiting
• 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

Study contacts

• Principal investigator: Umberto Ricardi, MD — SC Radioterapia U - AOU Città della Salute e della Scienza di Torino
• Study coordinator: Uffici Studi FIL
• Email: startup@filinf.it
• Phone: +390131033153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.