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A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload

A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload - A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007644
Enrollment
37
Registered
2012-04-03
Start date
2012-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion-induced iron overload

Interventions

Iron chelation therapy is performed early in patients with transfusion-induced iron overload. Iron chelation therapy is to start from low-dose administration at the discretion of the attending phys

Sponsors

Osaka Saiseikai Nakatsu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who have required two units or more red cell transfusion a month. (2) 500<=SF<=2,500 (3) aged 16 and over (4) Patients who had not received deferasirox. (5) Patients with an ECOG performance status of 0-1 (6) Patient who gave written informed consent before starting the screening test (by both a patient and a legal representative if a patient is minor).

Exclusion criteria

Exclusion criteria: (1) Patients with simultaneous multiple cancers. (2) Patients with severe liver or severe renal dysfunction. (3) Pregnant women or those with suspected pregnancy or nursing women (4) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. (5) Patients with history of hyper sensitivity to deferasirox. (6) Patients with history of hematopoietic stem cell transplantation.

Design outcomes

Primary

MeasureTime frame
Treatment continuation rate at 12 months after the initiation of iron chelation therapy

Secondary

MeasureTime frame
(1) Changes of serum ferritin (2) Achievement rate of SF<1,000 (3) Achievement rate of SF<2,500 (4) Improvement of organ failure (heart, liver, pancreas) (5) Safety (6) Hematopoietic improvement (IWG2006 criteria) (7) total dose of transfusions (8) Concentration of EPO (9) Exposure of deferasirox

Countries

Japan

Contacts

Public ContactRyosuke Yamamura

Osaka Saiseikai Nakatsu Hospital Division of Hematology

yamamura@nakatsu.saiseikai.or.jp(06)6372-0333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026