UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000400 |
|---|---|
| Receipt number | R000000460 |
| Scientific Title | Phase 2 study of G-CSF priming chemotherapy for high risk myelodysplastic syndrome (MDS) and MDS/secondary AML |
| Date of disclosure of the study information | 2006/04/17 |
| Last modified on | 2018/10/04 18:07:25 |
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Basic information
Public title
Phase 2 study of G-CSF priming chemotherapy for high risk myelodysplastic syndrome (MDS) and MDS/secondary AML
Acronym
Phase 2 study of G-CSF priming chemotherapy for high risk MDS and MDS/secondary AML
Scientific Title
Phase 2 study of G-CSF priming chemotherapy for high risk myelodysplastic syndrome (MDS) and MDS/secondary AML
Scientific Title:Acronym
Phase 2 study of G-CSF priming chemotherapy for high risk MDS and MDS/secondary AML
Region
| Japan |
Condition
Condition
High risk myelodysplastic syndrome and MDS/secondary AML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the clinical efficacy and safety of G-CSF priming chemotherapy on high risk MDS and MDS/secondary AML.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete remission rate
Key secondary outcomes
Overall survival, event-free survival, relapse-free survival, toxicity
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
Remission induction therapy: G-CSF (lenograstim), sic, day0-7. Cytarabine (Ara-C) 100mg/sqm, cont-div, day1-7. Idarubicin (IDR) 12mg/sqm, 30 min-div, day1-3.
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Previously untreated RAEB-II or MDS/secondary AML (2)Age between 15 and 65 years old (3) Performance status between 0 and 2 (4) Adequate function of the liver (serum bilirubin level<2.0mg/dl), the kidney (serum creatinine level<2.0 mg/dl) and heart (no abnormalities seen on electrocardiograms and echocardiographs) (5)Written informed consent to participate the study
Key exclusion criteria
(1) Uncontrolled active infection (2) Other serious and/or life-threatening diseases (3) Another active primary malignancy (4) Severe mental retardation (5) Pregnant or lactating woman (6) Past illness of renal failure (7) Positive for HIV antibody and/or HBs antigen tests
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuda, MD, PhD |
Organization
Kinki University School of Medicine
Division name
Department of Hematology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuda, MD, PhD |
Organization
JALSG MDS206G study office
Division name
Department of Hematology, Kinki University School of Medicine
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
mmatsuda@med.kindai.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2006 | Year | 04 | Month | 17 | 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
| 2006 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000460
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| Registered date | File name |
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| Registered date | File name |
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