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Recruitment status Terminated
Unique ID issued by UMIN UMIN000007644
Receipt No. R000009016
Scientific Title A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Date of disclosure of the study information 2012/04/03
Last modified on 2018/10/08

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Basic information
Public title A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Acronym A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Scientific Title A prospective study of treatment continuation rate with early low-dose iron chelation therapy for patients with transfusion-induced iron overload
Scientific Title:Acronym 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
1st name
Middle name
Last name Kensuke Ohta
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of Hematology
Zip code
Address 2-10-39,Shibata,Kita-ku,Osaka,Japan
TEL (06)6372-0333
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Yamamura
Organization Osaka Saiseikai Nakatsu Hospital
Division name Division of Hematology
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 02 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009016


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