Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkin’s lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients.

INTERVENTION: Trade Name: DOXORUBICINA BAXTER*EV 20FL50M Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: gm/m2 gram(s)/square meter Concentration type: equal Concentration number: 20‐ Trade Name: BLEOMICINA NIPPON K.*1F 15MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bleomycin Concentration unit: g gram(s) Concentration type: equal Concentration number: 15‐ Trade Name: VINBLASTINA BAX*INFUS 1FL 10MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Vinblastine Concentration unit: g gram(s) Concentration type: equal Concentration number: 10‐ Trade Name: DETICENE*INFUS 100MG/10ML FL+F Pharmaceutical Form: Solution for infusion INN or Proposed INN: Dacarbazine Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 100‐ CONDITION: HODGKIN LYMPHOMA ; MedDRA version: 9.1 Level: LLT Classification code 10020205 Term: Hodgins PRIMARY OUTCOME: Main Objective: To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET‐2 positive), can be salvaged with an early shift to high‐dose chemotherapy supported by stem cell rescue. Primary end point(s): ­2 year event free survival (EFS) rate. Events are considered the disease progression, the late serious treatment‐related events, secondary cancers, and deaths from any cause. Secondary Objective: To analyse if patients entering an early complete response (PET‐2 negative), can be spared subsequent radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. In order to answer this question, PET‐2 negative patients are randomized between radiotherapy on initial bulky disease areas versus no radiotherapy. INCLUSION CRITERIA: ‐ Histologically confirmed diagnosis of Hodgkin?s lymphoma, with the exclusion of nodular lymphocyte predominance. ‐ Age 18‐70. ‐ Stage IIB‐IV. ‐ No prior therapy. ‐ ECOG performance status grades 0‐3 (see Appendix 4) ‐ FDG‐PET scan performed before treatment. ‐ Written Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range