Chemotherapy alone for early-stage Hodgkin lymphoma without radiation

Who can take part

• 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

Who cannot take part

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