UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006071
Receipt number	R000007182
Scientific Title	Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin
Date of disclosure of the study information	2011/08/31
Last modified on	2023/06/08 19:54:44

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Basic information

Public title

Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin

Acronym

HSCT for AA using low-dose ATG

Scientific Title

Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin

Scientific Title:Acronym

HSCT for AA using low-dose ATG

Region

Japan

Condition

SAA

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To evaluate the safety and efficacy of allogeneic HSCT for aplastic anemia using fludarabine, cyclophosphamide, and low-dose ATG

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Assessment

Primary outcomes

1-year overall survival

Key secondary outcomes

engraftment rate, rate of grade II-IV acute GVHD, rate of chronic GVHD, rate of mixed chimerism, rate of CMV disease, rate of PTLD

Base

Study type

Interventional

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

Conditioning regimen
Fludarabine
30mg/m2/day iv day-6,-5,-4,-3
Cyclophosphamide
25mg/kg/day iv day-6,-5,-4,-3
ATG(thymoglobulin)
1.25mg/kg iv day-4,-3

In case of HSCT from unrelated donor or HLA-mismatched related donor,
TBI 2Gy day-1 will be added.

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
1. Patients with severe acquired aplastic anemia
2. Patients who had received any kind of prior treatment other than HSCT will be included.
3. Patients who are 20 to 65 years old
4. Patients who have HLA matched related donor, single antigen mismatched related donor, HLA matched unrelated donor, and single DRB1 allele mismatched unrelated donor.
5. Patients in performance status of 0 or 1.
6. Patients whose major organ functions are preserved.
7. Patients from whom informed consent are obtained

Key exclusion criteria

Exclusion criteria
1. Patients with poorly controlled DM
2. Patients with poorly controlled hypertension
3. Patients with poorly controlled active infection
4. Patients with chromosome 7 abnormality
5. Patients with coexistence of malignancy
6. Patients who are pregnant or nursing
7. Patients with serious mental disorder
8. Patients with HBs antigen or HBe antigen positive
9. Patients with HIV antibody positive
10. Patients who are allergic to drugs used in conditioning regimen
11. Patients who had undergone allogeneic HSCT

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Shinichiro Okamoto

Organization

Kanto Study Group for Cell Therapy

Division name

Chairman

Zip code

Address

Tokyo

TEL

03-6225-2040

Email

ksgctdc@ksgct.net

Public contact

Name of contact person

1st name

Middle name

Last name Shinichi Kako

Organization

Kanto Study Group for Cell Therapy

Division name

Trial Office

Zip code

Address

Saitama

TEL

048-647-2111

Homepage URL

Email

shinichikako@asahi-net.email.ne.jp

Sponsor or person

Institute

Kanto Study Group for Cell Therapy

Institute

Department

Personal name

Funding Source

Organization

None

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

2011 Year 08 Month 31 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://ash.confex.com/ash/2018/webprogram/Paper115105.html

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

2011 Year 07 Month 12 Day

Date of IRB

2013 Year 06 Month 24 Day

Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2018 Year 03 Month 16 Day

Date of closure to data entry

2018 Year 07 Month 05 Day

Date trial data considered complete

2018 Year 07 Month 09 Day

Date analysis concluded

2018 Year 11 Month 28 Day

Other

Other related information

Management information

Registered date

2011 Year 07 Month 29 Day

Last modified on

2023 Year 06 Month 08 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007182

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name