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| ID | Type | Description | Link |
|---|---|---|---|
| EudracT Number 2008-002684-14 |
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| Name | Class |
|---|---|
| Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte | OTHER |
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The purpose of this study is to define an improvement in patients:
This study is composed by two phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
PET-6 negative patients will be randomized to first arm: No radiotherapy. |
|
| Arm B | Other | Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
PET-6 negative patients will be randomized to second arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABVD | Drug | ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm A (Observation) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Levis, MD | Ospedale SS. Antonio, Biagio e Cesare Arrigo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di riferimento Oncologico Oncologia Medica A | Aviano | Italy | ||||
| Università Policlinico di Bari - Divisione di Medicina A |
| 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. | |
| 34597375 | Derived | Ricardi U, Levis M, Evangelista A, Gioia DM, Sacchetti GM, Gotti M, Re A, Buglione M, Pavone V, Nardella A, Nassi L, Zanni M, Franzone P, Frezza GP, Pulsoni A, Grapulin L, Santoro A, Rigacci L, Simontacchi G, Tani M, Zaja F, Abruzzese E, Botto B, Zilioli VR, Rota-Scalabrini D, Freilone R, Ciccone G, Filippi AR, Zinzani PL. Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial. Blood Adv. 2021 Nov 9;5(21):4504-4514. doi: 10.1182/bloodadvances.2021005150. |
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| ABVD and Radiotherapy | Drug | ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk). |
|
| Bari |
| Italy |
| Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica | Bologna | Italy |
| Sezione di Ematologia Spedali Civili | Brescia | Italy |
| Ospedale di Circolo SC Oncologia Medica III | Busto Arsizio | Italy |
| Divisione di Ematologia Osp.Businco | Cagliari | Italy |
| Policlinico Careggi Cattedra di Ematologia | Florence | Italy |
| ASLTO4 | Ivrea | Italy |
| Osp. Cardinale Panico Divisione di Ematologia Tricase | Lecce | Italy |
| Ospedale Niguarda Cà Granda | Milan | Italy |
| Università Avogadro Divisione di Ematologia | Novara | Italy |
| Ospedale San Francesco UO Ematologia e Centro Trapianti | Nuoro | Italy |
| Fondazione Policlinico San Matteo Clinica Ematologica | Pavia | Italy |
| Osp. Santa Maria delle Croci UO Ematologia | Ravenna | Italy |
| Ospedale Bianchi Melacrino Morelli | Reggio Calabria | Italy |
| Osp. degli Infermi Divisione di Oncologia | Rimini | Italy |
| Istituto Regina Elena IFO SC Ematologia | Roma | Italy |
| Osp.Sant'Eugenio Divisione di Ematologia | Roma | Italy |
| Università La Sapienza Dipartimento di Biotecnnologie Cellulari | Roma | Italy |
| Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia | Rozzano (MI) | Italy |
| AO Universitaria di Sassari | Sassari | Italy |
| Policlinico Le Scotte | Siena | Italy |
| Struttura Complessa di Onco-Ematologia | Terni | Italy |
| IRCC Onco-Ematologia Candiolo | Torino | Italy |
| Osp. San Giovanni Battista_Molinette Ematologia 2 | Torino | Italy |
| Azienda Ospedaliero universitaria di Udine | Udine | Italy |
| ASL 14 UO Oncologia | Verbania | Italy |
| 26884559 | Derived | Zinzani PL, Broccoli A, Gioia DM, Castagnoli A, Ciccone G, Evangelista A, Santoro A, Ricardi U, Bonfichi M, Brusamolino E, Rossi G, Anastasia A, Zaja F, Vitolo U, Pavone V, Pulsoni A, Rigacci L, Gaidano G, Stelitano C, Salvi F, Rusconi C, Tani M, Freilone R, Pregno P, Borsatti E, Sacchetti GM, Argnani L, Levis A. Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study. J Clin Oncol. 2016 Apr 20;34(12):1376-85. doi: 10.1200/JCO.2015.63.0699. Epub 2016 Feb 16. |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C034632 | ABVD protocol |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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