Last updated on August 2019

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

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03646123

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