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The results of the present study will provide information on short-term safety and efficacy of a iPET and MTV-adapted therapeutic strategy, aimed to assess the feasibility and safety on immediate disease control of a standard ABVD chemotherapy without any further treatment in patients with a very low risk or treatment failure. A second very important endpoint will be the efficacy of INRT "on demand" followed by Nivolumab maintenance for one year to rescue patients failing first-line treatment and relapsing with the pattern of "limited relapse" in terms of 3-Y failure from 2 relapse (FF2R). Patients entering into the study will be also asked to participate to a long-term follow up study (beyond ten years) to assess the prevalence of late-onset cardiovascular effects and secondary tumors in the cohort of patients enrolled in the experimental and control arm of the study. An exploratory endpoint has been also added such as the role of Minimal Residual Disease (MRD) detection by cell-free DNA assay on peripheral blood samples obtained during treatment in predicting long-term disease control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Nivolumab, total dose 5760 mg milligram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 10 MG/ML | Drug | Nivolumab, 100 mg, 10 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy exploration in terms of 3-Y PFS of chemotherapy alone | To explore the efficacy, in terms of 3-Y PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by both a low MTV and a negative interim PET after 2 courses of ABVD | During follow-up (36 months) after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy exploration in terms of 3-Y PFS of chemotherapy plus Nivolumab | To explore the efficacy in terms of 3-Y PFS of CMT plus Nivolumab in high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both | During follow-up (36 months) after the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan M Zaucha, Professor, PhD, MD | Contact | 58 584 43 40 | 0048 | jzaucha@gumed.edu.pl |
| Marta Bednarek, PhD | Contact | 58 349 18 85 | 0048 | marta.bednarek@gumed.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jan M Zaucha, Professor, PhD, MD | Medical University of Gdansk | Principal Investigator |
| Andrea Gallamini, Professor, PhD, MD | Research and Clinical Innovation Department of the Lacassagne Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Department IRCCS Policlinico San Matteo | Recruiting | Pavia | P.le Golgi 19 | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40135712 | Derived | Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Efficacy exploration in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance |
To explore the efficacy in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance in patients relapsing with the pattern of "limited relapse" (see below) for the entire group (relapsed and non-relapsed) of low-risk patients (with low MTV and negative PET- 2) high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both |
| During follow-up (36 months) after the end of treatment |
| Safety exploration in terms of 3-Y OS of a treatment with chemotherapy alone | To explore the safety in terms of 3-Y OS of a treatment with chemotherapy alone in low-risk early-stage (I-IIA) HL patients, defined by a low Metabolic Tumor Volume negative interim PET after 2 ABVD courses | During follow-up (36 months) after the end of treatment |
| Evaluation the ability of cell-free DNA (cfDNA) assay | To evaluate the ability of cell-free DNA (cfDNA) assay to detect an impending relapse during follow-up in low-risk patients treated with chemotherapy alone�k� | During follow-up (36 months) after the end of treatment |
| Ospedale Papa Giovanni XXIII | Not yet recruiting | Bergamo | Piazza OMS, 1 | 24127 | Italy |
|
| Istituto Europeo di Oncologia | Not yet recruiting | Milan | Via Giuseppe Ripamonti 435 | 20141 | Italy |
|
| Hematology Department Azienda Ospedaliera S. Croce e Carle | Not yet recruiting | Cuneo | Via Michele Coppino, 26 | 12100 | Italy |
|
| Azienda Ospedaliera Universitaria Policlinico Federico II | Recruiting | Naples | Via S.Pansini, 5 | 80131 | Italy |
|
| IRCCS Istituto Tumori Giovanni Paolo II | Not yet recruiting | Bari | Viale Orazio Flacco, 65 | 70124 | Italy |
|
| Policlinico Università Tor Vergata | Not yet recruiting | Roma | Viale Oxford, 81 | 00133 | Italy |
|
| Azienda Ospedaliero - Universitaria Ospedali Riuniti | Not yet recruiting | Ancona | Italy |
|
| Azienda Ospedaliera G. Brotzu - Ospedale Businco | Not yet recruiting | Cagliari | Italy |
|
| Divisione Universitaria di Onco-Ematologia | Not yet recruiting | Monza | Italy |
|
| Azienda Ospedaliera di Padova Dipartimento di Medicina Interna | Not yet recruiting | Padova | Italy |
|
| Ospedali Riuniti Villa Sofia | Not yet recruiting | Palermo | Italy |
|
| Gdański Uniwersytet Medyczny Department of Hematology and Transplantology | Recruiting | Gdansk | Poland |
|
| Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Not yet recruiting | Krakow | Poland |
|
| Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa | Not yet recruiting | Warsaw | Poland |
|
| Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu | Not yet recruiting | Wroclaw | Poland |
|
| Hospital Universitario Central de Asturias | Not yet recruiting | Oviedo | Av. Roma | 33011 | Spain |
|
| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | Avda de Córdoba | 28041 | Spain |
|
| Hospital Duran i Reynals. Institut Catala d'Oncologia | Not yet recruiting | Barcelona | Avinguda de La Granvia de l'Hospitalet, 199-203 | 08908 | Spain |
|
| Hospital Germans Trias i Pujol-ICO Badalona | Not yet recruiting | Carretera de Canyet | Barcelona | 08916 | Spain |
|
| Hospital Universitario Vall d'Hebron | Not yet recruiting | Passeig de La Vall d'Hebron, 119-129 | Barcelona | 08035 | Spain |
|
| Hospital Clinic de Barcelona | Not yet recruiting | Barcelona | C. de Villarroel, 170 | 08036 | Spain |
|
| Hospital General Universitario Gregorio Marañon | Not yet recruiting | Madrid | Calle Del Dr. Esquerdo | 28007 | Spain |
|
| Hospital Universitario Marques de Valdecilla | Not yet recruiting | Av. de Valdecilla, 25 | Cantabria | 39008 | Spain |
|
| Hospital Universitario Ramón y Cajal | Not yet recruiting | Madrid | Ctra. de Colmenar Viejo Km. 9,100 | 28034 | Spain |
|
| Hospital Universitario de Salamanca | Not yet recruiting | Salamanca | P.º de San Vicente, 58 | 37007 | Spain |
|
| Hospital Universitario Virgen del Rocio | Not yet recruiting | Av. Manuel Siurot | Sevilla | 41013 | Spain |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |