Efficacy and safety of triple iron chelator (deferoxamine, deferasirox, and deferiprone) versus dual iron chelator (deferoxamine and deferasirox) combination therapy for reducing iron overload in transfusion-dependent beta-thalassaemia with very high iron overload.

INTERVENTION: Patients with transfusion‐dependent beta‐thalassemia major with very high serum ferritin (>3500ng/mL) attending the Adult and Adolescent Thalassaemia Center of the Colombo North Teaching Hospital, Ragama, Sri Lanka, will be randomised into two groups using an online simple randomisation tool for an allocation ratio of 2:1 to intervention and control arms. The intervention arm will receive combination of oral deferasiro X40mg/kg/day + deferiprone 75mg/kg/day + deferoxamine 25‐40mg/kg/day at least 5 days a week for a total of 6 months The control arm will receive combination of oral deferasiro X40mg/kg/day + deferoxamine 25‐40mg/kg/day at least 5 days a week for a total of 6 months CONDITION: Thalassaemia PRIMARY OUTCOME: Reduction in iron overload, as measured by a reduction in the serum ferritin concentration after completion of the treatment. [Baseline, after completion of 6‐month treatment]; SECONDARY OUTCOME: Reduction in liver iron content as measured by T2* MRI of the liver [Baseline, after completion of 6‐month treatment]; Reduction in cardiac iron content as measured by T2* MRI of the heart [Baseline, after completion of 6‐month treatment]; Side effects of trial medication [ After completion of 6‐month treatment]; INCLUSION CRITERIA: 1. Male or female patients. 2. Transfusion‐dependent beta‐thalassemia major requiring at least eight transfusions per year. 3. Aged over 12 years. 4. Serum ferritin >3500ng/mL in the last two measurements done over the preceding 3‐month. 5. Currently on combination therapy with deferoxamine and deferasirox.