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Using Rigosertib to Treat Myelodysplastic Syndrome Study

Clinical Trial Title: 
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.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Jamile M. Shammo, MD
Clinical Trial Protocol Description: 

The purpose of this study is to determine how well the investigational study drug called rigosertib works on people with MDS and to study the safety of rigosertib when it is given to people with MDS. This is a randomized study. There is a 2 to 1 chance of being randomized to rigosertib group. The comparison arm is called “physician’s choice,” which means the health care provider will choose the therapy that is most appropriate after failing a hypomethylating agent.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have 5-30% BM blasts (MDS classified as RAEB-1, RAEB-2 according to WHO criteria, or RAEB-t according to FAB classification).
  • Have at least one cytopenia (ANC<1800uL or PLT count<100,000 or Hgb<10g/dL).
  • Have one or more of the following:
    • Progression at any time after initiation of AZA or DEC treatment.
    • Failure to achieve complete or partial response of HI after at least six 4-week cycles of AZA or either four 4-week or four 6-week of DEC.
    • Relapse after initial complete or partial response of HI.
    • Intolerance to AZA or DEC.

You will be excluded from the study if any of the following criteria apply to you:

  • Are eligible to receive allogenic stem cell transplant.
  • Are eligible to receive induction therapy, such as 7-10 days of cytosine arabinoside and 2-3 days of an anthracycline, or high-dose cytarabine.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-1346
Contact Name: 
Kimberly Koetter