Conditions: Myelodysplastic Syndrome Transfusional Iron Overload
Keywords: Gastrointestinal adverse events, myelodysplastic syndrome, transfusional iron overload diarrhea, constipation abdominal pain, vomiting
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

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:

Arms:
arm 1: Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food arm 2: Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal

Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: None

Protocol document: