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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003365
Receipt No. R000004090
Scientific Title A prospective study of leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade)
Date of disclosure of the study information 2010/04/01
Last modified on 2013/03/27

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Basic information
Public title A prospective study of leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade)
Acronym A prospective study of leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade)
Scientific Title A prospective study of leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade)
Scientific Title:Acronym A prospective study of leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade)
Region
Japan

Condition
Condition Myelodysplastic syndome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the leukemic transformation control and hematopoietic recovery in patients with myelodysplastic syndrome(MDS) receiving iron chelation therapy with deferasirox(Exjade), and we examine the role of serum hepcidin in MDS patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The marker about iron overload once three months.
Bone marrow aspiration after one year.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients with MDS are administered Deferasirox a once-daily dose of 5 mg/kg.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1, The iron overload patients (age 20-85) with MDS in WHO classification.
2, The Serum ferritin(SF) level is above the normal range.
Key exclusion criteria 1, heavy renal and liver disorder.
2, during pregnancy, the lactation period.
3, allergy to Deferasirox
4, The case who cannot receive informed consent from patients.
5, The patients who received chemotherapy, except for oral chemoterapy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Maeda
Organization Showa University School of Medicine
Division name Division of Hematology, Department of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8338
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Maeda
Organization Showa University School of Medicine
Division name Division of Hematology, Department of Medicine
Zip code
Address
TEL 03-3784-8338
Homepage URL
Email

Sponsor
Institute Division of Hematology, Department of Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization Division of Hematology, Department of Medicine, Showa University School of Medicine
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
2010 Year 04 Month 01 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 Completed
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 23 Day
Last modified on
2013 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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