Trial Search Results

Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

The purpose of this study was to evaluate deferasirox and placebo with regard to event-free survival (EFS) (a composite primary endpoint including death and non-fatal events related to cardiac and liver function and transformation to AML) in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Deferasirox
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Weigh between 35-135 kilograms

   - Low or int-1 risk MDS

   - Ferritin >1000 micrograms/liter at screening

   - History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units

   - Anticipated to be transfused with at least 8 units of PRBCs annually during the study

   - Women of child-bearing potential using effective methods of contraception during
   dosing of study treatment

Exclusion Criteria:

   - More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or
   deferiprone or 5×/week deferoxamine)

   - More than 3 years since patient began receiving regular transfusions (2 units per 8
   weeks or 4 units received in a 3 month period)

   - Significant proteinuria

   - History of hospitalization for congestive heart failure; other heart conditions as
   specified in the protocol

   - Systemic diseases which would prevent study treatment

   - Hepatitis B; Hepatitis C; HIV

   - Liver cirrhosis

   - Pregnant, or breast-feeding patients, or patients of child-bearing potential not
   employing an effective method of birth control

   - History of drug or alcohol abuse within the 12 months prior to enrollment

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