UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000220 |
|---|---|
| Receipt number | R000000286 |
| Scientific Title | Randmized controlled trial to test set-therapy and individualized-therapy for elderly acute myelocytic leukemia |
| Date of disclosure of the study information | 2005/09/20 |
| Last modified on | 2009/03/25 07:23:18 |
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Basic information
Public title
Randmized controlled trial to test set-therapy and individualized-therapy for elderly acute myelocytic leukemia
Acronym
Randmized controlled trial to test set-therapy and individualized-therapy for elderly acute myelocytic leukemia
Scientific Title
Randmized controlled trial to test set-therapy and individualized-therapy for elderly acute myelocytic leukemia
Scientific Title:Acronym
Randmized controlled trial to test set-therapy and individualized-therapy for elderly acute myelocytic leukemia
Region
| Japan |
Condition
Condition
acute myelocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to establish the best therapy for elderly acute myelocytic leukemia, we test set-therapy and individualized-therapy
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
complete remission rate, survival period
Key secondary outcomes
over all survival rate, event-free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
set therapy
Interventions/Control_2
individualised therapy
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
| 65 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Previously untreated AML
Age between 66 and 80 years
Performance status between 0 and 2(ECOG criteria)
Serum bilirubin level <2.0mg/dl
Serum creatinine level <2.0mg/dl
Oxygen saturation >= 90%
Left ventricular ejection fraction >= 50%
Key exclusion criteria
History of acute myocardial infarction within 1 year
History of renal insuficiancy
Poorly controlled diabetes
Poorly controleed angina
Uncontrolled active infection
Liver cirrohsis
Severe psychiatric disease
Positive for HIV antibody
Positive for HCV antibody
Positive for HBs antigen
Target sample size
288
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Wakita, MD |
Organization
Higashi Municipal Hospital of Nagoya
Division name
Hematology and Oncology
Zip code
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya, JAPAN
TEL
052-721-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Wakita, MD |
Organization
Higashi Municipal Hospital of Nagoya
Division name
Hematology and Oncology
Zip code
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya, JAPAN
TEL
052-721-7171
Homepage URL
http://www2.hama-med.ac.jp/w4a/jalsg/seika/igaiyo/GML200.htm
wakita@higashi-hosp.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Adult Leukemia Study Group
Health and Labour Science Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2005 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
http://www2.hama-med.ac.jp/w4a/jalsg/seika/igaiyo/GML200.htm
Publication of results
Partially published
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
| 1999 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2000 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2009 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000286
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
