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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000186
Receipt No. R000000257
Scientific Title Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Date of disclosure of the study information 2005/09/12
Last modified on 2016/11/02

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Basic information
Public title Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Acronym Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Scientific Title Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Scientific Title:Acronym Phase III study comparing FK506 with Cyclosporine A for prophylaxis of acute graft-versus-host disease after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation (C-SHOT 0404)
Region
Japan

Condition
Condition Acute leukemia,
Chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to establish the optimal prophylaxis of acute GVHD after HLA-A, B and DRB1 genotypically matched unrelated bone marrow transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Methotrexate and Tacrolimus (FK506) for GVHD prophylaxis
Interventions/Control_2 Methotrexate and Cyclosporine A for GVHD prophylaxis
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
16 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria 1. HLA-A, B, DRB1 genotypically matched unrelated bone marrow transplantation
2. Acute leukemia (1st CR, 2nd CR)
Chronic myeloid leukemia (1st CP,
2nd CP, AP)
3.Age :between 16 and 50.
4. Performance status:between 0 and 2
5. Preserved organ (liver, kidney, heart and lung) function: serum bilirubin level < 1.5 mg/dl, GOT and GPT level <= 2 times the upper limit of the normal range, serum creatinin level < 1.2 mg/dl, Ccr>=60ml/min, left ventricular ejection fraction>=50%, PaO2>=70mmHg.
6. Written informed consent
Key exclusion criteria 1. Previous transplantation.
2. Use of T cell depleted marrow.
3. Use of ATG and ALG for preparative
regimen.
4. Severe dysfunction of kidney, liver
and lung.
5. History of severe cardiac disease
6. History of pancreatitis and diabetes
mellitus.
7. Hyperkelemia (>=5.5mEq/l)
8. Hypertension necessitating
medication.
9. Active infection (including hepatitis
B, hepatitis C, HIV, syphilis)
10. History of allergy or allergic
response to drugs
11. Pregnant or lactating woman
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Kodera
Organization Japanese Red Cross Nagoya First Hospital
Division name Department of Internal Medicine
Zip code
Address 3-35 Michishita-cho Nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Atsuta
Organization Center for Supporting Hematology-Oncology Trials (C-SHOT)
Division name Center for Supporting Hematology-Oncology Trials (C-SHOT)
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi, 466-8550, Japan
TEL 052-745-3116
Homepage URL http://www.c-shot.or.jp/
Email c-shot@med.nagoya-u.ac.jp

Sponsor
Institute Health and Labour Sciences Research Grants,Research on Human Genome,Tissue Engineering,Ministry of Health,Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
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
2005 Year 09 Month 12 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
1999 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
1999 Year 08 Month 01 Day
Last follow-up date
2009 Year 01 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
2005 Year 09 Month 12 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000257

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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