Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING

Prior treatment

• Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection;
• Active autoimmune disorder in treatment with immunosuppressive drugs

Other illness

• Myocardial infarction within 2 years of study entry.
• Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters);
• Extra nodal site involved by disease;
• Uncompensated diabetes mellitus requiring insulin therapy;
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol;
• Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA;
• Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA;

Lab values

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma;
• A left-ventricular ejection fraction < 50%;
• Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug;

Other

• Severely impaired, lung and renal function;
• Pregnancy or lactation
• B symptoms;

• Male or female patients aged 18-70.
• Total bilirubin must be < 2.0 x the upper limit of normal (ULN) unless known Gilbert syndrome
• ALT or AST must be < 3 x the upper limit of normal.
• Female patients: if postmenopausal for at least 1 year before enrolment or, if fertile - agreeing to practice 2 effective methods of contraception or agreeing to practice true abstinence.
• Male patients should agree to practice barrier contraception or to practice abstinence
• Treatment-naïve, classical HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A);
• Patients must have histologically confirmed classical HL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocytes rich, lymphocytes depleted, or classical HL NOS [not otherwise specified];
• ECOG performance status 0-2
• Hemoglobin must be > 8 gr./dL
• Absolute neutrophil count ≥ 1,000/μL
• Platelet count ≥ 100,000/μL
• Voluntary written consent to take part to the study
• Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute