UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)
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	Yoshihisa Kodera
Organization	Japanese Red Cross Nagoya First Hospital
Division name	Department of Internal Medicine
Address	3-35 Michishita-cho Nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL
Email

Public contact
Name of contact person	Yoshiko Atsuta
Organization	Center for Supporting Hematology-Oncology Trials (C-SHOT)
Division name	Center for Supporting Hematology-Oncology Trials (C-SHOT)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	1999 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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