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

Status: Active

Description

This trial will study a treatment combination for Hodgkin lymphoma. The drugs used in this trial are a targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are referred to as "A+AVD." Patients will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses). The trial will look at whether the drug combination reduces the number of patients who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening.

Eligibility Criteria

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

Locations & Contacts

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Treatment

Lead Organization

Lead Organization
Seattle Genetics

Trial IDs

Primary ID SGN35-027
Secondary IDs NCI-2018-01922
Clinicaltrials.gov ID NCT03646123