Myelodysplastic Syndrome (MDS) 04-30

A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent.

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Eligibility Criteria:

1. MDS classified as follows:
   • RAEB-1 per World Health Organization (WHO) MDS criteria (5% to <10% BM blasts).
   • RAEB-2 per WHO MDS criteria (10% to <20% BM blasts).
   • RAEB-t per French-American-British (FAB) classification (20% to 30% BM blasts).
2. At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL).
3. Progression (according to 2006 IWG criteria) at any time after initiation of AZA or DAC treatment or Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least six 4-week cycles of AZA or either four 4-week or four 6-week cycles of DAC administered or Relapse after initial complete or partial response or HI (according to 2006 IWG criteria)

This study is for patients age 18 and older.

Available at: Hospital of Central Connecticut