Trial Search Results
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
Stanford is currently not accepting patients for this trial.
- Drug: decitabine
- Drug: azacitidine
Subjects who meet all of the following criteria may be included in the study:
1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1
transfusion dependent, Intermediate-2, or High-risk [defined by International
Prognostic Scoring System (IPSS) score of ≥0.5] and recognized French-American-British
2. Male or female, 18 years of age or older with signed informed consent
3. Adequate renal function
4. Demonstrated normal liver function
5. Female subjects of childbearing age must have negative pregnancy test within 1 week of
study entry and agree to use adequate contraception for the duration of the trial and
for a minimum of six months after last dose of decitabine or azacitidine received.
6. Male subjects must agree to use adequate contraception for the duration of the trial
and for a minimum of six months after last dose of decitabine or azacitidine received.
Subjects who meet any of the following criteria will be excluded from participation in the
1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering
study (permitted if > 2 weeks from study entry and if recovered from toxic effects of
2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing
signs or symptoms of infection and without improvement despite appropriate treatment)
3. Pregnancy or current lactation
4. Significant concurrent disease, illness, or psychiatric disorder
5. Treatment with an investigational agent 30 days prior to the first dose of decitabine
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study