Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Inc.
Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS
Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.
Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
You may not be if
1. Prior therapy with decitabine or azacytidine (Vidaza).
2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
3. Clinically significant anemia.
4. Prior history of malignancy other than MDS.
5. Any active infection.
6. Radiotherapy within 14 days prior to study enrollment.
Clareo Health | A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
