Hodgkin Lymphoma Treatment with Brentuximab Vendotin and Gemcitabine – Phase I/II

Brentuximab Vedotin in Combination with Gemcitabine for Pediatric and Young Adult Patients with Relapsed or Refractory Hodgkin Lymphoma

Protocol Description

This multicenter trial by the Children’s Oncology Group studies the side effects, best dose, and effectiveness of brentuximab vedotin when given together with gemcitabine hydrochloride in treating younger patients with Hodgkin lymphoma that has returned or does not respond to other treatment. Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them, and may kill more cancer cells when given together with gemcitabine hydrochloride.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 13 months to 30 years of age, who have been diagnosed with Hodgkin disease that is recurrent or has not responded to treatment.
Males and Females: Ages 13 months to 30 years

Requirements

In 3-week cycles, study participants will be given brentuximab vedotin and gemcitabine via intravenous infusion on the first cycle day. On the eighth cycle day an infusion of gemcitabine will be repeated. Participants will be evaluated every two cycles to determine whether they should remain in the study or go off the study for another treatment.
Visits: Weekly visits during cycle 1, then twice every 3-week cycle
Duration: Up to 16 cycles, or approximately 1 year

Status: Open to Enrollment

Source(s) of Support

Cancer Therapies Evaluation Program
Children’s Oncology Group (AHOD1221)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864