NCT01900509

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

A Phase I Trial of Bendamustine in Combination With Clofarabine and Etoposide in Pediatric Patients With Relapsed or Refractory Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bendamustine will be combined with clofarabine and etoposide in a five-day cycle. Dexamethasone will be given to prevent capillary leak syndrome associated with clofarabine. If the participant does not develop progressive disease or a dose-limiting toxicity (DLT) during the first cycle, a second cycle may be administered as a bridge to transplant. Each cycle lasts 21-28 days (or until count recovery). Concomitant intrathecal therapy can be given at the investigator's discretion, but not on the same days as chemotherapy. Recommendations are triple intrathecal therapy (methotrexate, hydrocortisone, cytarabine) weekly for participants with CNS2 or CNS3 disease, and every two weeks for participants with CNS1 disease. Leucovorin may be given according to institutional guidelines. The intent of this study design is for all participants to receive and complete one course of therapy. Participants who exhibit signs of disease progression or experience an unacceptable toxicity will be discontinued from protocol treatment.

Conditions

• Hodgkin Lymphoma
• Non-Hodgkin Lymphoma
• Acute Leukemia

Interventions

Type	Name	Description
DRUG	Bendamustine	Route of administration: intravenously (IV) over approximately 60 minutes, days 1-5.
DRUG	Clofarabine	Route of administration: IV days 1-5.
DRUG	Etoposide	Route of administration: IV days 1-5.
DRUG	Etoposide phosphate	Route of administration: Used in substitution for etoposide in participants who experience allergic reaction, Etopophos® will be administered IV.
DRUG	Dexamethasone	Route of administration: three times daily orally (by mouth), days 1-5.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-07-16
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study