Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes.

ABSTRACT:

Purpose

This open-label, randomized phase II trial assessed efficacy and tolerability of two low-dose regimens of subcutaneous (SC) decitabine in patients with low- or intermediate-1-risk myelodysplastic syndrome (MDS).

Patients and methods

Patients received decitabine 20 mg/m(2) SC per day for 3 consecutive days on days 1, 2, and 3 every 28 days (schedule A) or 20 mg/m(2) SC per day once every 7 days on days 1, 8, and 15 every 28 days (schedule B) for up to 1 year. Primary efficacy end point was overall improvement rate (OIR: complete remission [CR], partial remission [PR], marrow CR [mCR], or hematologic improvement [HI]). Secondary end points were HI, transfusion independence, cytogenetic response, overall survival (OS), and time to acute myeloid leukemia or death.

Res

SUBMITTER: Garcia-Manero G 

PROVIDER: S-EPMC4878053 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature