A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Brentuximab Vedotin
Intervention description: Brentuximab vedotin IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Hodgkin; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases; Additional Relevant MeSH terms:; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, T-Cell; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions

Summary:

      This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy
      and safety of brentuximab vedotin as a single agent in adult participants with histologically
      confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a
      prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or
      multiagent chemotherapy at the time of study entry.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant must meet all of the following inclusion criteria to be enrolled in the
        study:

          1. Male or female participants 18 years or older, with relapsed or refractory classical
             Hodgkin lymphoma (HL), who have previously received at least 1 prior systemic
             chemotherapeutic regimen

          2. Not suitable for stem cell transplantation (SCT) or multiagent chemotherapy, according
             to 1 of the following criteria:

               -  Disease progression within 90 days of the earliest date of complete remission
                  (CR) or complete remission unconfirmed (CRu) after the end of treatment with
                  multiagent chemotherapeutic regimens and/or radiotherapy

               -  Progressive disease during frontline multiagent chemotherapy

               -  Disease relapse after treatment with at least 2 chemotherapeutic regimens,
                  including any salvage treatments

          3. Bidimensional measurable disease

          4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

          5. Female participants who are postmenopausal for at least 1 year before the screening
             visit, surgically sterile, or agree to practice 2 effective methods of contraception
             at the same time, or agree to practice true abstinence.

          6. Male participants who agree to practice effective barrier contraception during the
             entire study treatment period through 6 months after the last dose of study drug or
             agree to practice true abstinence.

          7. Clinical laboratory values as specified in the study protocol.

        Exclusion Criteria:

        Participants who meet any of the following exclusion criteria are not to be enrolled in the
        study:

          1. Previous treatment with brentuximab vedotin

          2. Previously received an autologous stem cell transplantation (ASCT) or alloSCT

          3. Known cerebral/meningeal disease, including signs or symptoms suggestive of
             progressive multifocal leukoencephalopathy (PML), or any history of PML.

          4. Female participants who are lactating and breastfeeding or pregnant.

          5. Known human immunodeficiency virus (HIV).

          6. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C
             infection.

          7. Grade 2 or higher peripheral neuropathy.