Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT02943668|
Recruitment Status : Terminated (Terminated due to low accrual)
First Posted : October 25, 2016
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anemia Myelodysplastic Syndrome||Drug: Deferasirox Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the activity of iron chelation therapy (ICT) with deferasirox, in patients with anemia due to myelodysplastic syndrome (MDS).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Deferasirox in Patients With Myelodysplastic Syndromes Who Are Anemic With Iron Overload|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||December 17, 2018|
|Actual Study Completion Date :||December 17, 2018|
Experimental: Treatment (deferasirox)
Patients receive deferasirox PO QD. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Other Name: Exjade
Other: Laboratory Biomarker Analysis
- Proportion of patients that achieve erythroid hematologic improvement. [ Time Frame: At 6 months ]As defined by the modified International Working Group (IWG) response criteria.
- Change in red blood cell (RBC) transfusion requirements [ Time Frame: Baseline up to 12 months ]Assessed monthly for up to twelve months.
- Change in serum ferritin levels [ Time Frame: Baseline up to 12 months ]Assessed monthly for up to twelve months.
- Incidence of adverse events [ Time Frame: Up to 12 months ]As measured by grade 3 and 4 non-hematologic adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.
- Proportion of patients who achieve granulocyte or platelet hematologic improvement [ Time Frame: At 6 months ]As defined by the modified IWG response criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943668
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Bart Scott||Fred Hutch/University of Washington Cancer Consortium|