A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India

Inclusion Criteria22

• Treatment-naïve, Hodgkin lymphoma (HL) participants with Ann Arbor Stage 3 or 4 disease.
• Note: Participants must have histologically confirmed classical HL according to the current world health organization classification.
• Participants must have bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred) per the international working group revised criteria for response assessment for malignant lymphoma.
• Male or female participants 18 years or older.
• Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.
• Female participants 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 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the informed consent form (ICF) through 6 months after the last dose of study drug, OR
• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
• Male participants, even if surgically sterilized (i.e., status post-vasectomy), who:
• 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 practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
• Voluntary written 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• Clinical laboratory values as specified below within 7 days before the first dose of study drug:
• Absolute neutrophil count greater than or equal to (≥)1,000 per microliter (1,000/μL) unless there is known HL marrow involvement
• Platelet count ≥75,000/μL unless there is known HL marrow involvement
• Total bilirubin must be lesser than (\<)1.5 x upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be \<3.0 x ULN. An AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.
• Note: Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria.
• Serum creatinine must be \<2.0 milligrams per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance \>30 mL/minute (Cockcroft-Gault Equation).
• Hemoglobin must be ≥8 grams per deciliter (g/dL).