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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000400
Receipt No. 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

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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
Email

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
Email mmatsuda@med.kindai.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000460

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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