drugset / Trial / NCT00795613
Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL)
Phase 2
Unknown
450 enrolled
Ospedale Santa Croce-Carle Cuneo
Consorzio Mario Negri Sud · collabGITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy.
Timeline
- Start
- 2008-06
- Primary completion
- 2014-11
- Completion
- 2015-10
Publications
- Background Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.
- Background Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, Luminari S, Vitolo U, Sancetta R, Iannitto E, Trentin L, Stelitano C, Tavera S, Biggi A, Castagnoli A, Versari A, Gregianin M, Pelosi E, Torchio P, Levis A. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica. 2006 Apr;91(4):475-81.
- 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.
- Gallamini A, Rossi A, Patti C, Picardi M, Romano A, Cantonetti M, Oppi S, Viviani S, Bolis S, Trentin L, Gini G, Battistini R, Chauvie S, Sorasio R, Pavoni C, Zanotti R, Cimminiello M, Schiavotto C, Viero P, Mule A, Fallanca F, Ficola U, Tarella C, Guerra L, Rambaldi A. Consolidation Radiotherapy Could Be Safely Omitted in Advanced Hodgkin Lymphoma With Large Nodal Mass in Complete Metabolic Response After ABVD: Final Analysis of the Randomized GITIL/FIL HD0607 Trial. J Clin Oncol. 2020 Nov 20;38(33):3905-3913. doi: 10.1200/JCO.20.00935. Epub 2020 Sep 18.
- Gallamini A, Tarella C, Viviani S, Rossi A, Patti C, Mule A, Picardi M, Romano A, Cantonetti M, La Nasa G, Trentin L, Bolis S, Rapezzi D, Battistini R, Gottardi D, Gavarotti P, Corradini P, Cimminiello M, Schiavotto C, Parvis G, Zanotti R, Gini G, Ferreri AJM, Viero P, Miglino M, Billio A, Avigdor A, Biggi A, Fallanca F, Ficola U, Gregianin M, Chiaravalloti A, Prosperini G, Bergesio F, Chauvie S, Pavoni C, Gianni AM, Rambaldi A. Early Chemotherapy Intensification With Escalated BEACOPP in Patients With Advanced-Stage Hodgkin Lymphoma With a Positive Interim Positron Emission Tomography/Computed Tomography Scan After Two ABVD Cycles: Long-Term Results of the GITIL/FIL HD 0607 Trial. J Clin Oncol. 2018 Feb 10;36(5):454-462. doi: 10.1200/JCO.2017.75.2543. Epub 2018 Jan 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 10 mg/m2 | Intravenous |
| Subject | Bleomycin | Unknown | 10000 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 650 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1250 mg/m2 | Intravenous |
| Subject | Dacarbazine | Small molecule | 375 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vinblastine | Small molecule | 6 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | procarbazine | Small molecule | 100 mg/m2 | Oral |
| Background | G-CSF | Unknown | 300 ug | Subcutaneous |