UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015647
Receipt number	R000018190
Scientific Title	Safety and efficacy of conditioning regimen with once-daily intravenous busulfan and fludarabine or cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myelogenous leukemia or myelodysplastic syndrome
Date of disclosure of the study information	2014/11/10
Last modified on	2018/11/15 15:36:50

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Basic information

Public title

Safety and efficacy of conditioning regimen with once-daily intravenous busulfan and fludarabine or cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myelogenous leukemia or myelodysplastic syndrome

Acronym

Efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for HSCT in AML/MDS

Scientific Title

Scientific Title:Acronym

Efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for HSCT in AML/MDS

Region

Japan

Condition

acute myelogenous leukemia, myelodysplastic syndrome

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

This study evaluate safety and efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for allogeneic stem cell transplantation in AML/MDS patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

event-free survival at day 100 from transplantation

Key secondary outcomes

Base

Study type

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

once-daily intravenous busulfan

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

16 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

PS (ECOG) is 0 to 2
no sever organ dysfunction (T.Bil<2.0 mg/dL, AST/ALT =>3XUNL, CCr<2.0mg/dl, EF>50%, SpO2>95%)
patients will survive more than three months
AML(without FAB M3) or MDS
patients transplant from following donors:
HLA (A, B, DR) 6/6 allele matched related or unrelated donor
HLA (A, B, DR) 5/6 allele matched related or unrelated donor
less than 2 HLA (A, B, DR) antigens mismatched cord blood with =>2X10E7/kg nuclear cells
patients obtained informed consent

Key exclusion criteria

patients with antibody of HIV
patients has other malignancies
patients has uncontrollable psychiatric disorders
patients has active infections
patients has history of hematopoietic stem cell transplantation
patients has allergy of the drugs that use in protocol
pregnant woman

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Toshiro Ito

Organization

Shinshu University of School of Medicine

Division name

Second Department of Internal Medicine

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-357-2634

Email

itot@shinshu-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Toshiro Ito

Organization

Shinshu University of School of Medicine

Division name

Second Department of Internal Medicine

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2634

Homepage URL

Email

itot@shinshu-u.ac.jp

Sponsor or person

Institute

Second Department of Internal Medicine, Shinshu University of School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Second Department of Internal Medicine, Shinshu University of School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

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

2014 Year 11 Month 10 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

Open public recruiting

Date of protocol fixation

2014 Year 03 Month 04 Day

Date of IRB

Anticipated trial start date

2014 Year 03 Month 04 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 11 Month 10 Day

Last modified on

2018 Year 11 Month 15 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018190

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name