A Safety Study of Growth Factor Use in Treatment With Brentuximab Vedotin Plus Chemotherapy

This study will evaluate the impact of granulocyte colony stimulating factor primary
prophylaxis (G-PP) administration during treatment with A+AVD on the incidence of febrile
neutropenia, efficacy, and dose intensity in patients with advanced stage Hodgkin lymphoma.
Patients will be treated using institutional standard of care practices for the majority of
treatment decisions. A+AVD will be administered on days 1 and 15 of a 28-day cycle, with the
addition of G-PP 24-36 hours postdose. Patients will receive 6 cycles of treatment.

Inclusion Criteria:

- Treatment-naïve, Hodgkin lymphoma (HL) patients with Ann Arbor Stage 3 or 4 disease

- Histologically confirmed classical HL according to the current World Health
Organization (WHO) Classification

- Bidimensional measureable disease as documented by radiographic technique

Exclusion Criteria:

- Nodular lymphocyte predominant HL

- History of another malignancy within 2 years of the first dose of study drug or any
evidence of residual disease from a previously diagnosed malignancy. Patients with
nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type
are not excluded if they have undergone complete resection.

- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy
within 12 weeks of the first study drug dose

- Active cerebral/meningeal disease related to the underlying malignancy

- Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of
the first dose of study drug (Grade 3 defined by the National Cancer Institute's
Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)

- Current therapy with other systemic anti-neoplastic or investigational agents

- Grade 3 or higher pulmonary disease unrelated to underlying malignancy

- History of a cerebral vascular event within 6 months of first dose of study drug

- Child-Pugh B or C hepatic impairment

- Any peripheral sensory or motor neuropathy

- Patients who are pregnant or breastfeeding

- Other serious condition that would impair the patient's ability to receive or tolerate
the planned treatment and follow-up