ENSAYO CLÍNICO

Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial. A biopsy at the time of relapse / demonstration of primary refractoriness is highly recommended. Patients diagnosed with 1st relapsed/refractory HL (treatment escalation or de-escalation, performed according to interim PET-CT result in first-line therapy, will still be considered as a single prior line, i.e., RATHL or LYSARC trials) will also be considered candidates for the trial. Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female patients 18 years or older up to 65 years of age 2. Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care 3. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 highly effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse 4. Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse 5. ECOG performance status 0 to 2 6. Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm) 7. No evidence of neuropathy grade ≥2 8. Clinical laboratory values as specified below within 7 days before the first dose of study drug: · Absolute neutrophil count ≥ 1,500/µL unless there is known hematologic/solid tumor marrow involvement · Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease · Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome. · ALT or AST must be < 3 x the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver · Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute · Hemoglobin must be ≥ 8g/dL

Patients meeting any of the following exclusion criteria are not to be enrolled in the study. 1. Lymphocyte predominant nodular Hodgkin’s lymphoma 2. Prior treatment with brentuximab vedotin 3. Female patient who is both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug 4. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol. 5. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML) Symptomatic neurologic disease compromising normal activities of daily living or requiring medic 6. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 7. Known history of any of the following cardiovascular conditions · Myocardial infarction within 2 years of enrollment · New York Heart Association (NYHA) Class III or IV heart failure (see Appendix #9)65 · Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities · Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction.

To determine metabolic complete remission (mCR) (PET-CT negative, Deauville scores 1 and 2) after 3 cycles of ESHAP-brentuximab vedotin (BV) vs ESHAP as salvage strategies in patients with relapsed / refractory classical Hodgkin’s Lymphoma (cHL)