Trial Search Results

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

The primary purpose of this study is to prospectively assess the efficacy and safety of iron chelation therapy with deferasirox compared to placebo 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: Deferasirox placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Males or females ≥ 18 years of age

   - Patients must weigh between 35-135 kg MDS low -int-1 risk as determined by IPSS score
   and confirmed by bone marrow examination within 6 months prior to study entry

   - Ferritin> 1000 mcg/L at screening

   - History of 15 to 75 PRBC transfusions

   - Anticipated to be transfused at least 8 times annually during the study

Exclusion Criteria:

   - More than 6 months of cumulative iron-chelation therapy (such as daily deferasirox
   (Exjade) or deferiprone or 5x/week deferosamine). intermittent deferoxamine doses in
   association with blood transfusions are not exclusionary regardless of duration of
   such treatment.

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

   - Creatinine clearance < 40 ml/min

   - Serum creatinine >1.5x ULN at screening

   - Significant proteinuria: urinary protein/creatinine ratio >0.5 mg/mg in a non first
   void urine sample

   - ECOG performance status > 2

   - Left ventricular ejection fraction < 50% by ECHO

   - History of hospitalization for Congestive Heart Failure

   - Systemic disease that would prevent study treatment (uncontrolled hypertension,
   cardiovascular renal, hepatic (including Child-Pugh Class B and C) or metabolic
   disease)

   - Hepatitis B or C (HBsAg in the absences or HBsAB or HCV Ab positive with HCV RNA
   positive)

   - History of HIV positivity by (ELISA or Western blot)

   - Treatment with systemic investigational drug within 4 weeks or topical investigational
   drug within 7 days of study start

   - ALT or AST > 3.5 x ULN at screening

   - Total bilirubin > 1.5 x ULN at screening

   - Diagnosis of liver cirrhosis

   - Patient participating in another clinical trial or receiving an investigational drug

   - History of another malignancy within the past five years, with the exception of basal
   skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps
   carcinoma in situ

   - History of non-compliance with medical regimen, or patients potentially unreliable
   and/or not cooperative

   - Presence of surgical or medical condition which might significantly alter the
   absorption, distribution, metabolism or excretion of study drug

   - Pregnant or intending to become pregnant or breast-feeding patents

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

   - Other protocol-defined inclusion/exclusion criteria may apply

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