None listed
Conditions
Brief summary
In the present study, after two courses of standard Doxorubicin Bleomycin Vinblastine Dacarbazine (ABVD) treatment patients will be evaluated for chemosensitivity by Positron Emission Tomography (PET): patients with a positive scan will be addressed to a more aggressive therapy with either escalated Bleomycin Etoposide Doxorubicin Cyclophosphamide Vincristine Procarbazine Prednisone (BEACOPP) or escalated Rituximab-Bleomycin Etoposide Doxorubicin Cyclophosphamide Vincristine Procarbazine Prednisone (R-BEACOPP); patients with a negative scan will continue the standard therapy.
Interventions
All participants receive the initial therapy that consists in 2 courses of Doxorubicin (25 mg/m2 intravenous (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) (ABVD). After this two cycles (cycle repeats every 28 days) a early PET will be performed. If PET is positive the participants will be randomized to 4 (cycles repeat every 21 days) escalated Bleomycin (10 mg/m2/endovenous (ev)/day, day 8), Etoposide (200 mg/
All participants receive the initial therapy that consists in 2 courses of Doxorubicin (25 mg/m2 intravenous (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) (ABVD). After this two cycles (cycle repeats every 28 days) a early PET will be performed. If PET is positive the participants will be randomized to 4 (cycles repeat every 21 days) escalated Bleomycin (10 mg/m2/endovenous (ev)/day, day 8), Etoposide (200 mg/m2/ev/day, days 1-3), Doxorubicin (35 mg/m2/ev/day, day 1), Cyclophosphamide (1250 mg/m2/ev/day, day 1), Vincristine (1,4 mg/m2/ev/day, day 8), Procarbazine (100 mg/m2/b.m./day, days 1-7), Prednisone (40 mg/m2/b.m./day, days 1-14),(BEACOPPesc) or escalated Bleomycin (10 mg/m2/ev/day, day 8), Etoposide (200 mg/m2/ev/day, days 1-3), Doxorubicin (35 mg/m2/ev/day, day 1), Cyclophosphamide (1250 mg/m2/ev/day, day 1), Vincristine (1,4 mg/m2/ev/day, day 8), Procarbazine (100 mg/m2/b.m./day, days 1-7), Prednisone (40 mg/m2/b.m./die 1°-14°), Rituximab (375 mg/m2/ev/day, day 1) (R-BEACOPPesc). After participants will be received another PET.
Sponsors
Gruppo Italiano Terapie Innovative nei Linfomi (GITIL)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
-Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification -Aged 18-60 -Not previously treated -Stages IIB to IV B -All International Prognostic Score (IPS) prognostic groups -Patients who have signed an informed consent form
Exclusion criteria
-Patients aged more than 60. -Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin’s lymphoma. -Psychiatric disorders -Uncontrolled infectious disease -Impaired cardiac (Ejection Fraction (EF) < 50%) , renal (creatinine clearance < 60 ml/m) -Human Immunodeficiency Virus (HIV) Hepatitis B Virus Deoxyribonucleic Acid(HBV DNA), Hepatitis C Virus Ribonucleic Acid (HCV RNA) positive markers -Pregnancy and lactation -Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
Outcome results
None listed