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

NCT01900509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sima Jeha, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900509 on ClinicalTrials.gov