Phase 1 study of bendamustine in combination with clofarabine, etoposide, and dexamethasone in pediatric patients with relapsed or refractory hematologic malignancies.

ABSTRACT:

Background

A phase 1 study was conducted to determine the maximum tolerated dose of bendamustine when given in combination with clofarabine, etoposide, and dexamethasone daily for 5 days in children and adolescents with relapsed or refractory hematologic malignancies.

Methods

Patients younger than 22 years with second or greater relapsed or refractory acute leukemia or lymphoma after 2 or more prior regimens were eligible. With the rolling 6 design, participants received escalating doses of bendamustine (30, 40, or 60 mg/m² /d) in combination with clofarabine (40 mg/m² ), etoposide (100 mg/m² ), and dexamethasone (8 mg/m² ) daily for 5 days. Optional pharmacokinetic studies were performed in cycle 1 on day 1 and day 5.

Results</

SUBMITTER: Jeha S 

PROVIDER: S-EPMC8710083 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature