UMIN-CTR Clinical Trial

Unique ID issued by UMIN	C000000186
Receipt number	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 10:46:00

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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

Scientific Title

Scientific Title:Acronym

Region

Japan

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

Concealment

Central registration

Intervention

No. of arms

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 or person

Institute

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

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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