Patient-Level Meta-analysis of Clofarabine in Acute Lymphoblastic Leukemia.

ABSTRACT:

Introduction

Clofarabine monotherapy at a dose of 52 mg/m² per day was approved in the USA in 2004 for the treatment of relapsed or refractory acute lymphoblastic leukemia (R/R ALL) in patients aged 1-21 years after at least two prior regimens. To address a post-marketing requirement for additional evidence of the clinical benefit of clofarabine in its approved indication, a meta-analysis of patient-level data was conducted.

Methods

A systematic literature review was conducted, using the Dr.Evidence software platform, DOC Search, and Embase, to identify clinical trials with patients with R/R ALL who received clofarabine monotherapy at 52 mg/m². The primary endpoint was complete remission (CR). Secondary endpoints were overall remission (OR, defined by C

SUBMITTER: Jeha S 

PROVIDER: S-EPMC10611855 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature