Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies

• Status: Completed
• Trial end date: 2016-05-01

Summary

Participants with relapsed or refractory leukemia or lymphoma will be recruited for this study to find whether or not the addition of a new drug called bendamustine will be safe and possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug Administration (FDA) for the treatment of other cancers in adults that are similar to those being studied in the research trial.

PRIMARY OBJECTIVES

• To establish the maximum tolerated dose (MTD) of bendamustine in combination with clofarabine and etoposide in pediatric participants with hematologic malignancies.

• To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine in combination with clofarabine and etoposide.

SECONDARY OBJECTIVES

• To estimate event-free survival at 4 months.

• To estimate minimal residual disease (MRD) levels present at end of each cycle of therapy in participants with leukemia.

• To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.

• Phase: Phase 1

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: Teva Pharmaceuticals USA
• Treatments: BB 1101; Bendamustine Hydrochloride; Clofarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate