EUCTR2009-012418-38-GBActive, not recruitingPhase 1
A multi-centre, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO) - TELESTO
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 225
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Male or female , =18 years of age
- •Weight between 35-135kg
- •Patients with with low or intermediate (int-1) risk MDS, as determined by IPSS score. This must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable.
- •Ferritin > 1000 mcg/L at screening
- •Serum ferritin will be measured at Screening Visit 1 and Screening Visit 2 (at least 14 days apart) and the mean value will be used for eligibility criteria.
- •History of transfusion of 15 to 75 PRBC units
- •Anticipated to be transfused with at least 8 units of PRBCs annually during the study
- •Additional inclusion criteria as per full protocol may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 83
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
Exclusion Criteria
- •More than 6 months of cumulative iron chelation therapy (such as daily deferasirox (Exjade) or deferiprone or 5x/week deferoxamine).
- •- 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 > 1.5 x ULN at screening
- •- Serum creatinine will be measured at Screening Visit 1 and Screening Visit 2 (at least 14 days apart) and the mean value will be used for eligibility criteria.
- •Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at Visit 1 or Visit 2 (or alternatively in two of three samples obtained for screening)
- •ECOG performance status > 2
- •Left ventricular ejection fraction < 50% by echocardiography as per the central reading assessment.
- •A history of hospitalization for congestive heart failure
- •Systemic diseases which would prevent study treatment (e.g.uncontrolled hypertension, cardiovascular, renal, hepatic (including Child-Pugh Class B and C), metabolic, etc.)
- •Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive)
- •History of HIV positive test result (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 × ULN at screening
- •Total bilirubin >1.5 x ULN at screening
- •Diagnosis of liver cirrhosis (either established diagnosis or diagnosis by liver biopsy or central ultrasound reading).
- •Patients participating in another clinical trial other than an observational registry study
- •Patients with a 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 to medical regimens, or patients who are considered potentially unreliable and/or not cooperative
- •Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
- •Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control (see Women of child-bearing potential, below, for futher details regarding effective methods of birth control).
- •History of drug or alcohol abuse within the 12 months prior to enrollment
Investigators
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