Spots Global Cancer Trial Database for Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

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Trial Identification

Brief Title: Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

Official Title: A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

Study ID: NCT01326845

Conditions

Myelodysplastic Syndrome

Transfusional Iron Overload

Interventions

Deferasirox

Study Description

Brief Summary: The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

Detailed Description: