Phase I combination trial of lenalidomide and azacitidine in patients with higher-risk myelodysplastic syndromes.

ABSTRACT:

Purpose

Lenalidomide and azacitidine are active in patients with lower- and higher-risk myelodysplastic syndromes (MDS). These agents may complement each other by targeting both the bone marrow microenvironment and hypomethylating action on the malignant clone.

Patients and methods

This phase I trial explored the safety of combination therapy in patients with higher-risk MDS. Response and characterization of molecular and methylation status of responders were secondary objectives. Patients were enrolled using a 3 + 3 dose escalation. Cycles lasted 28 days, and patients received a maximum of seven cycles.

Results

Of 18 patients enrolled, median age was 68 years (range, 52 to 78 years), interval from diagnosis was 5 weeks (range, 2 to 106 weeks), and follow-up was 7 mon

SUBMITTER: Sekeres MA 

PROVIDER: S-EPMC2860439 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature