NCT02943668

Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome

A Phase II Study of Deferasirox in Patients With Myelodysplastic Syndromes Who Are Anemic With Iron Overload

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well deferasirox works in treating patients with very low, low, or intermediate-risk anemia or myelodysplastic syndrome that depends on red blood cell transfusions. Deferasirox may treat too much iron in the blood caused by blood transfusions.

Detailed description

PRIMARY OBJECTIVES: I. To assess the activity of iron chelation therapy (ICT) with deferasirox, in patients with anemia due to myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. Reduction in red blood cell (RBC) transfusion requirements. II. Hematologic improvement. III. Change in serum ferritin levels from baseline to the end of the study as measured on a monthly basis. IV. Safety and tolerability of deferasirox. EXPLORATORY OBJECTIVES: I. Blood and marrow samples will be taken to study erythropoiesis and the impact of iron overload on erythropoiesis. OUTLINE: Patients receive deferasirox orally (PO) once daily (QD). Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Anemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Deferasirox	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-03-02
• Primary completion: 2018-12-17
• Completion: 2018-12-17
• First posted: 2016-10-25
• Last updated: 2020-07-01
• Results posted: 2020-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study