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.

Lead Sponsor:

Eisai Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: decitabine
  • Drug: azacitidine

Phase:

Phase 4

Eligibility


Inclusion Criteria

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
   (FAB) classifications

   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.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the
study:

   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
   therapy)

   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
   or azacitidine

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting