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

OVARTIS FARMA0 sites630 target enrollmentNovember 19, 2009

Conditionsmyelodysplastic syndromes(low/int-1 risk)MedDRA version: 12.1Level: LLTClassification code 10019613Term: Hemosiderosis

DrugsEXJADE

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: myelodysplastic syndromes(low/int-1 risk)
Sponsor: OVARTIS FARMA
Enrollment: 630
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 19, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OVARTIS FARMA

Eligibility Criteria

Inclusion Criteria

•\-Male or female patients, ≥18 years of age \-Patient must weigh between 45\-120 kg \-Patients 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 and \< 2500 mcg/L at screening History of transfusion of 20 to 50 PRBC units Chelation\-na?ve patients Anticipated to be transfused at least 8 times 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
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•\-More than 3 years since diagnosis of MDS \-Creatinine Clearance \<40 ml/min \-Serum creatinine \> ULN 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 \< 55% 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 and ALT above the normal range) \-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 \> 2\.5 ? ULN at screening \-Total bilirubin \> ULN at screening Diagnosis of liver cirrhosis Patients participating in another clinical trial or receiving an investigational drug \-Patients with a history of another malignancy within the past five years, with the exception of basel 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 Patients who are found to be ineligible after screening procedures will have this documented on the screening log. These patients will not need to complete the end of study assessments.