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Leuk Lymphoma. 2014 Jun;55(6):1332-6. doi: 10.3109/10428194.2013.838764. Epub 2013 Nov 1.

Phase I study of GTI-2040, a ribonucleotide reductase antisense, with high dose cytarabine in patients with relapsed/refractory acute myeloid leukemia.

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  • 1Division of Hematology, Department of Medicine.

Abstract

We hypothesized that GTI-2040, a 20-mer oligonucleotide complementary to the R2 subunit mRNA of ribonucleotide reductase, combined with high dose cytarabine (HiDAC) would result in enhanced cytotoxicity by favoring Ara-CTP DNA incorporation. In a phase I dose escalation trial, adults (≥ 60 years) with refractory or relapsed acute myeloid leukemia (AML) received daily HiDAC plus infusional GTI-2040. Using a novel assay, evidence of intracellular drug accumulation and target R2 down-regulation was observed. GTI-2040/HiDAC can be administered safely. However, with no complete remissions observed, alternative doses and schedules may need to be investigated to achieve clinical activity in older patients with AML.

KEYWORDS:

Acute myeloid leukemia; GTI-2040; antisense therapy; phase I study; ribonucleotide reductase

PMID:
24015841
PMCID:
PMC4298748
DOI:
10.3109/10428194.2013.838764
[PubMed - indexed for MEDLINE]
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