Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study (MACS1574)
Myelodysplastic Syndrome, Transfusional Iron Overload
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Gastrointestinal adverse events,, myelodysplastic syndrome,, transfusional iron overload diarrhea,, constipation abdominal pain,, vomiting
Eligibility Criteria
Inclusion Criteria:
- Written informed consent prior to any screening procedures
- Male or female patients ≥ 18 years of age
- Patient must weigh between 45-135 kg
- Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or RA, RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable
Deferasirox naïve:
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
Exclusion Criteria:
- History or current GI disease
- Systemic diseases which could prevent study treatments
- Left ventricular ejection fraction< 50 % by echo cardiography
- Serum creatinine > 1.2 x ULN at screening
- Platelet counts < 25x 109/L except in cases where guidance is already given in the local deferasirox label
- AST or ALT > 2.5 xULN at screening
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Deferasirox am
Deferasirox pm
Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
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