Clinical trial NCT02292979 (phase 2, status: active, not recruiting)
Conditions: hodgkin lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: doxorubicin, bleomycin, vinblastine, dacarbazine, brentuximab vedotin
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, C[C@@H](O)[C@H](NC(=O)[C@@H](C)[C@H](O)[C@@H](C)NC(=O)[C@@H](NC(=O)C1=C(C)C(N)=NC(=N1)[C@H](CC(N)=O)NC[C@H](N)C(N)=O)[C@@H](OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(OC(N)=O)C1O)C1=CN=CN1)C(=O)NCCC1=NC(=CS1)C1=NC(=CS1)C(=O)NCCC[S+](C)C, N[C@@H](CCCNC(N)=N)C(O)=O, N1C=CN=C1, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed CD30+ classical Hodgkin lymphoma

          -  Supradiaphragmatic Ann Arbor clinical stage I or II

          -  Previously untreated

          -  PET scan without IV contrast at diagnosis available for central review with at least
             one hypermetabolic lesion

          -  Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical
             prognostic factors, including patients with at least one of the following factors:

               -  CSII ≥ 4 nodal areas

               -  age ≥ 50 yrs

               -  M/T ratio ≥ 0.35

               -  ESR ≥ 50 (without B-symptoms) or ESR ≥ 30 with B-symptoms

          -  ECOG performance status 0-2

          -  Life expectancy > 6 months

          -  Age 18 to 60 years

          -  Availability for periodic blood sampling, study-related assessments, and management of
             toxicity at the treating institution.

          -  Female patients who:

               -  Are postmenopausal for at least 1 year before the screening visit, OR are
                  surgically sterile, OR

               -  If they are of childbearing potential, agree to practice 2 effective methods of
                  contraception, at the same time, through 6 months after the last dose of study
                  drug, OR agree to completely abstain from heterosexual intercourse

          -  Male patients, even if surgically sterilized (ie, status postvasectomy), who:

             o Agree to practice effective barrier contraception during the entire study treatment
             period and through 6 months after the last dose of study drug, or agree to completely
             abstain from heterosexual intercourse.

          -  Written informed consent.

          -  Required baseline laboratory data:

               -  Absolute neutrophil count ≥ 1,500/µL

               -  Platelet count ≥ 75,000/ µL

               -  Hemoglobin ≥ 8g/dL

               -  Serum total bilirubin ≤ 1.5 X ULN unless the elevation is known to be due to
                  Gilbert syndrome.

               -  Serum creatinine ≤ 2.0 mg/dL and/or calculated creatinine clearance > 40
                  mL/minute (Cockcroft-Gault formula or MDRD)

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN

        Exclusion Criteria:

          -  Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte
             predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded.

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

          -  Any sensory or motor peripheral neuropathy ≥ Grade 2

          -  Known history of any of the following cardiovascular conditions

               -  Myocardial infarction within 2 years of randomization

               -  New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)

               -  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 30 days before first dose of study drug) of a
                  left-ventricular ejection fraction <50%

          -  Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).

          -  Known HIV positive

          -  HCV positive

          -  HBV positive. This means:

               -  HBsAg positive

               -  HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral
                  DNA (HBsAg negative patients and viral DNA negative and patients seropositive due
                  to a history of hepatitis B vaccine are eligible).

          -  Any history of cancer during the last 5 years, with the exception of non-melanoma skin
             tumors. Carcinoma in situ of any type not excluded if complete resection.

          -  Dementia or altered mental status

          -  Pregnancy or breastfeeding.

          -  Previous treatment with any anti-CD30 antibody.

          -  Known hypersensitivity to any excipients contained in the BV formulation or known
             contra-indication to any drug contained in the chemotherapy regimens

          -  Treatment with corticosteroids before baseline PET scan

          -  Known active viral, bacterial, or fungal infection requiring treatment with
             antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or
             fungal infection, within 2 weeks prior to the first dose of BV

          -  Treatment with any investigational drug within 30 days before first cycle of treatment