Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02943668
Status:
TERMINATED
Last Update Posted:
2020-07-01
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Deferasirox in Patients With Myelodysplastic Syndromes Who Are Anemic With Iron Overload
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-01457 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 9422 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |