Clinical trial NCT02243436 (phase 1/phase 2, status: completed)
Conditions: classical hodgkin lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: brentuximab vedotin, etoposide, soludomerin, cisplatin, ara c
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Eligibility criteria:

        Inclusion Criteria:

        Patients must have fully recovered from the acute toxic effects of all prior chemotherapy,
        immunotherapy, or radiotherapy prior to entering this study

          -  Histologically confirmed relapsed or refractory classical HL after first line
             chemotherapy. CD30 has to be positive

          -  Age 18 to 65 years. Patient >65 years old with ECOG ≤1 and absence of comorbidities
             will be included in the study

          -  ECOG ≤2

          -  Karnofsky performance status ≥ 60

          -  No major organ dysfunction

          -  Biopsy at HL relapse or when refractoriness disease is diagnosed must be done prior to
             BV-ESHAP. If biopsy cannot be performed, tumor biopsy at initial diagnosis of HL must
             be available to be revised

          -  Absence of prior history of other malignant diseases, except:

        Basal cell carcinoma of the skin or uterine "in situ" carcinoma adequately treated Any
        curable neoplasia adequately treated that has achieved complete response and has remained
        in such status longer than 3 years

          -  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
             effective methods of contraception, at the same time, from the time of signing the
             informed consent through 30 days after the last dose of study drug, or agrees to
             completely abstain from heterosexual intercourse

          -  Male patients, even if surgically sterilized, 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

          -  Life-expectancy >3 months

          -  Platelet count ≥75•109/L (or 20 if due to Bone Marrow [BM] infiltration) absolute
             neutrophil count ≥1.5•109/L (or 0.5 if due to BM infiltration), and hemoglobin ≥ 8g/dL

          -  Total Bilirubin: <1.5 x UNL, unless clearly related to the disease (Gilbert disease
             will be ruled out from this point)

          -  AST and ALT: <3 xUNL except liver infiltration

          -  Serum creatinine: < 2.0 mg/dL and/or creatinine clearance or calculated creatinine
             clearance > 40 mL/minute

          -  Serum sodium >130 mmol/L

          -  Voluntary written informed consent

        Exclusion Criteria:

          -  Current active hepatic or biliary disease (with exception of patients with Gilbert's
             syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease
             per investigator assessment)

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study

          -  Patients that have been treated previously with anti-CD30 monoclonal antibodies

          -  Myocardial infarction within 6 months prior to enrollment. Heart failure NYHA Class
             III-IV, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
             of acute ischemia or active conduction system abnormalities. Recent evidence (within 6
             months) of a left-ventricular ejection fraction <50%

          -  Peripheral neuropathy or neuropathic pain grade ≥ 2

          -  Known cerebral or meningeal disease, including signs or symptoms of PML

          -  Symptomatic neurologic disease compromising normal activities of daily living or
             requiring medication

          -  Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
             contained in brentuximab vedotin

          -  Pregnant women or in breast-feeding period, or adults in childbearing period not using
             an effective contraception method

          -  Treatment with any known non-marketed drug substance or experimental therapy within
             the longer of 5 terminal half-lives or 4 weeks prior to enrollment or currently
             participating in any other interventional clinical study

          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
             antiviral treatment within two weeks prior to first study drug dose

          -  History of significant cerebrovascular disease in the past 6 months or ongoing event
             with active symptoms or sequelae

          -  HIV positive

          -  Significant concurrent, uncontrolled medical condition which may represent a risk for
             the patient

          -  Positive serology for HBV

          -  Positive serology for HCV