A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
Condition: Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic
Intervention: brentuximab vedotin; Brentuximab vedotin and rifampicin
Intervention description: Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.; Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
Intervention MeSH terms: Rifampin; Brentuximab Vedotin; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Lymphoma; Hodgkin; Anaplastic Large-cell; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases

Summary:

      This is an open-label trial to estimate the concentrations of brentuximab vedotin in
      relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large
      cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab
      vedotin + rifampicin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between 18 years and 75 years old, with relapsed or
             refractory HL or relapsed or refractory sALCL who have previously received at least 1
             multiagent chemotherapy

          -  Measurable disease

          -  An Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

          -  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, from the time of signing the informed consent form through 30 days
             after the last dose of study drug, or agree to practice true abstinence

          -  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

          -  Clinical laboratory values as specified in the study protocol

        Exclusion Criteria:

          -  Participants for whom rifampicin is contraindicated

          -  Previously received an allogeneic transplant.

          -  Participants with current diagnosis of primary cutaneous anaplastic large cell
             lymphoma (ALCL) (participants whose ALCL has transformed to sALCL are eligible).

          -  Known cerebral/meningeal disease including signs or symptoms of progressive multifocal
             leukoencephalopathy (PML)

          -  Female participants who are lactating and breastfeeding or pregnant

          -  Known human immunodeficiency virus (HIV) positive,

          -  Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection