drugset / Trial / NCT01780662

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT01780662

Phase 1/2 Completed 46 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with gemcitabine hydrochloride and to see how well they work in treating younger patients with Hodgkin lymphoma that has returned or does not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may find cancer cells and help kill them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin together with gemcitabine hydrochloride may kill more cancer cells.

Timeline

Start
2013-01-31
Primary completion
2017-09-30
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.4 mg/kg Intravenous
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications