Overview

A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy

Eligibility

Inclusion Criteria:

        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
          -  Male or female patients 18 to 65 years of age
          -  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             consent may be withdrawn by the patient at any time without prejudice to future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
          -  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 6 months after the last dose of study drug, or agrees to
             completely abstain from heterosexual intercourse
          -  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
          -  ECOG 0 to 2
          -  Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least
             1.5 cm)
          -  No evidence of neuropathy grade ≥2
          -  Clinical laboratory values as specified in the protocol below within 7 days before the
             first dose of study drug
        Exclusion Criteria:
          -  Lymphocyte predominant nodular Hodgkin's lymphoma
          -  Prior treatment with brentuximab vedotin
          -  Female patient who are 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
          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to the protocol.
          -  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
          -  Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
          -  Known history of any of the following cardiovascular conditions defined in the
             protocol
          -  Any active systemic viral, bacterial, or fungal infection requiring systemic
             antibiotics within 2 weeks prior to first study drug dose
          -  Patients that have not completed any prior treatment chemotherapy and/or other
             investigational agents within at least 5 half-lives (or 28 days if the half-lives are
             unknown) of last dose of that prior treatment
          -  Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
             contained in the drug formulation of brentuximab vedotin.
          -  Known human immunodeficiency virus (HIV) positive
          -  Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection
          -  Focal radiation therapy within 30 days prior to study recruitment
          -  Major surgery within 28 days prior to randomization
          -  Diagnosed or treated for another malignancy within 3 years before the first dose or
             previously diagnosed with another malignancy and have evidence of residual disease.
          -  Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not
             excluded if they have undergone complete resection.