UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Title of the study (Brief title)	A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Region	Japan

Condition
Condition	Transfusion-induced iron overload
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We consider whether it is possible to increase the treatment continuation rate by initiating the early low-dose iron chelation therapy in patients with transfusion-induced iron overload.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Treatment continuation rate at 12 months after the initiation of iron chelation therapy
Key secondary outcomes	(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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 physician.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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).
Key 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.
Target sample size	37

Research contact person
Name of lead principal investigator	Kensuke Ohta
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Division of Hematology
Address	2-10-39,Shibata,Kita-ku,Osaka,Japan
TEL	(06)6372-0333
Email

Public contact
Name of contact person	Ryosuke Yamamura
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Division of Hematology
Address	2-10-39,Shibata,Kita-ku,Osaka,Japan
TEL	(06)6372-0333
Homepage URL
Email	yamamura@nakatsu.saiseikai.or.jp

Sponsor
Institute	Osaka Saiseikai Nakatsu Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 22 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 02 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009016