A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO) - TELESTO

Phase 1

• Conditions: Transfusional iron overload; MedDRA version: 14.1Level: LLTClassification code 10019613Term: HemosiderosisSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2009-012418-38-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Male or female , =18 years of age, 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.
• Weight between 35-135 kg
• Ferritin > 1000 mcg/L at screening
• History of transfusion of 15 to 75 pRBC units
• Chelation-naïve patients
• Anticipated to be transfused with at least 8 units of pRBC annually during the study
• Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation
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 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315

Exclusion Criteria

• More than 6 months of cumulative iron chelation therapy (such as daily deferasirox or deferiprone or 5x/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)
• Creatinine Clearance <40 ml/min
• Serum creatinine > 1.5xULN at screening
• 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
• A history of hospitalization for congestive heart failure
• Systemic diseases which would prevent study treatment (e.g.uncontrolled hypertension, cardiovascular, renal, hepatic, 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
• 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
• 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, intending-to-become pregnant, or breast-feeding patients
• History of drug or alcohol abuse within the 12 months prior to enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified