UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003365 |
|---|---|
| Receipt number | 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 13:17:39 |
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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
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
Sponsor or person
Institute
Division of Hematology, Department of Medicine, Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004090
