Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
Condition: Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic
Intervention: Brentuximab Vedotin
Intervention description: Brentuximab vedotin IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of
      brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+
      Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have histologically confirmed CD30+ hodgkin lymphoma (HL) or systemic anaplastic large
             cell lymphoma (sALCL). Immunohistochemistry or flow cytometry may be performed on
             either original diagnostic biopsy material or biopsy of relapsed disease, and
             pathology reports of CD30+ or their copies should be retained at the site.

          2. With CD30+ HL or sALCL who have relapsed from or are refractory to previous
             treatments.

          3. Fluorodeoxyglucose (FDG)- positron emission tomography (PET) positive and measurable
             disease of at least 1.5 cm in the longest diameter by computed tomography (CT), as
             assessed by the site.

          4. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          5. Suitable venous access for the study-required blood sampling, including
             pharmacokinetic (PK) sampling.

          6. Must have the following required screening laboratory data. Participants must not have
             received recombinant granulocyte-colony stimulating factor (G-CSF) or platelet
             transfusion within 1 week before the screening hematology assessment.

               1. Absolute neutrophil count ≥1500/μL.

               2. Platelet count ≥75,000/μL.

               3. Serum bilirubin level ≤1.5 times the upper limit of the normal range (ULN).

               4. Serum creatinine level ≤1.5 times the ULN.

               5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
                  the ULN.

          7. Survival for 3 or more months must be expected.

        Exclusion Criteria:

          1. With current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL)
             (participants with other organ involvement who have transformed to sALCL are
             eligible).

          2. With any active viral, bacterial, or fungal infection within 2 weeks before the first
             dose of brentuximab vedotin.

          3. With cardiac failure categorized as Class III or IV according to the New York Heart
             Association criteria, uncontrolled coronary artery disease or uncontrolled arrhythmia
             despite of appropriate medical therapy, or a history of myocardial infarction within 6
             months before the first dose of brentuximab vedotin.

          4. With uncontrolled diabetes mellitus.

          5. Peripheral neuropathy ≥Grade 2.

          6. With a history of another malignancy that has not been in remission for at least 3
             years. The following are exempt from the 3-year limit:

               1. Nonmelanoma skin cancer.

               2. Curatively treated localized prostate cancer.

               3. Cervical carcinoma in situ.

          7. With known cerebral/meningeal disease (HL or any other etiology), including signs or
             symptoms of progressive multifocal leukoencephalopathy (PML).

          8. With a positive result in the screening test for human immunodeficiency virus (HIV)
             antibody.

          9. Known hepatitis B virus (HBV) surface antigen seropositive or positive hepatitis C
             virus (HCV) antibody. Note: participants who have positive HBV core antibody can be
             enrolled but must have an undetectable HBV viral load.

         10. With a history of liver fibrosis or cirrhosis and clinical signs and symptoms
             indicating liver fibrosis or cirrhosis.

         11. Have received autologous stem cell transplantation (auto-SCT) within 12 weeks before
             the first dose of brentuximab vedotin.

         12. With history of allogeneic stem cell transplantation (allo-SCT).

         13. Have received treatment for malignancies (including radiation, chemotherapy, and
             hormone therapy) within 4 weeks before the first dose of brentuximab vedotin and
             participants who have received treatment for malignancies with biologics (including
             molecular target drug) or radioisotopic therapy within 12 weeks before the first dose
             of brentuximab vedotin.

         14. Have unresolved toxicity higher than Grade 1 (National Cancer Institute Common
             Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03) attributed to any
             prior therapy/procedure (excluding alopecia or non-clinically significant and
             asymptomatic laboratory abnormalities).

         15. Have received systemic corticosteroids at doses greater than the equivalent of 20
             mg/day of prednisone within 1 week before the first dose of brentuximab vedotin.

         16. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, would make the participant inappropriate for entry into this
             study or interfere significantly with the proper assessment of the safety and toxicity
             of the prescribed regimens.