HD0607.

Trial name or title	PET‐adapted chemotherapy in advanced HL
Methods	Study design Initial treatment for 2 cycles ABVD (cycle repeats every 28 days) followed by FDG PET PET‐negative Continue with ABVD every 28 days for 4 further cycles Re‐evaluation with PET at the end of chemotherapy PET2 (after 2 cycles) ‐negative = CR (complete remission) Consolidation radiotherapy on the sites of initial bulky disease No further treatment PET‐positive BEACOPPesc (Be) plus BEACOPPbaseline (Bb) (4+4 courses) Be+Bb (4+4) and rituximab (R)
Participants	Age 18‐60 years Gender Both Inclusion criteria Participants with advanced classic HL according to the WHO classification Not previously treated Stages IIB to IV B All IPS prognostic groups Participants who have signed an informed consent form Country Israel, Italy
Interventions	Chemotherapy ABVD Doxorubicine 25 mg/m2 IV days 1,15; bleomycin 10,000 units/m2 IV days 1,15; vinblastine 6 mg/m2 IV days 1,15; dacarbazine 375 mg/m2 IV days 1,15 This will be given at full dose and on schedule, regardless of blood count. Growth factors may be used at the discretion of investigators but are not routinely advised BEACOPPesc Bleomycin 10 mg/m2/day 8; VP‐16 200 mg/m2/day1‐3; doxorubicine 35 mg/m2/day 1; cyclophosphamide 1250 mg/m2/day 1; vincristine 1.4 mg/m2(max dose 2 mg)/day 8; procarbazine 100 mg/m2/day 1‐7; prednisone 40 mg/m2/day 1‐14; G‐CSF 300 µg/day SC from day 8 until PMN > 1000/µl Recycle every 21 days BEACOPPbaseline Bleomycin 10 mg/m2/day 8; VP‐16 100 mg/m2/day 1‐3; doxorubicine 25 mg/m2/day 1; cyclophosphamide 650 mg/m2/day 1; vincristine 1.4 mg/m2(max dose 2 mg)/day 8; procarbazine 100 mg/m2/day 1‐7; prednisone 40 mg/m2/day 1‐14 Recycle every 21 days Rituximab 375 mg/m2/day 1 Recycle every 21 days Radiotherapy 'Involved field technique', at the dose of 30 Gy FDG‐PET
Outcomes	Progression‐free survival Event‐free survival
Starting date	June 2008
Contact information	Andrea Gallamini, MD Tel: +39 0171 642414 gallamini.a@ospedale.cuneo.it
Notes	Estimated enrolment: 450 Estimated completion date: July 2015 Study status according to ClinicalTrials.gov: this study is currently recruiting participants

ABVD: adriamycin, bleomycin, vinblastine, and dacarbazine; ANC: absolute neutrophil count; BEACOPP: bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone; CNS: central nervous system; CS: clinical staging; CT: computed tomography; ECHO: Echocardiogram; ECOG: Eastern Cooperative Oncology Group; esc: escalated; FDG: fluorodeoxy‐D‐glucose; G‐CSF: granulocyte colony‐stimulating factor; HIV: human immunodeficiency virus; HL: Hodgkin lymphoma; IPS: IV: intravenous; LVEF: left ventricular ejection fraction; N/A: not available; NCI CTCAE v 3.0: National Cancer Institute, Common Terminology Criteria for Adverse Events Version 3.0; PET: positron emission tomography; PFS: progression‐free survival; SC: subcutaneous; WHO: World Health Organization