UMIN-CTR Clinical Trial

Recruitment status	Main results already published
Unique ID issued by UMIN	UMIN000007913
Receipt No.	R000009310
Scientific Title	HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab
Date of disclosure of the study information	2012/06/01
Last modified on	2019/11/15 (Ver. 11)

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Basic information

Public title

HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab

Acronym

HLA-mismatched HSCT using low-dose alemtuzumab

Scientific Title

HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab

Scientific Title:Acronym

HLA-mismatched HSCT using low-dose alemtuzumab

Region

Japan

Condition

advanced hematological malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

Objectives
Narrative objectives1	To evaluate the efficacy of HLA-mismatched allogeneic HSCT for advanced hematological malignancy using low-dose alemtuzumab
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival rate at 60 days after transplantation with the engraftment of donor cells and without grade III-IV GVHD
Key secondary outcomes

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: Patients who are intolerable to conventional conditioning regimen due to either higher age (55>=), previous ASCT, organ dysfunction, or active infection will receive regimen 2-1 or 2-2. The other patients will receive regimen 1.

Regimen 1
Cyclophosphamide
60mg/kg/day iv. for 2 days
TBI
2Gy twice daily for 3 days
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)

Regime 2-1
Fludarabine
25mg/m2/day iv. for 5 days
Melphalan
40mg/m2/day iv. for 2 days
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)

Regimen 2-2
Fludarabine
30mg/m2/day iv. for 6 days
Busulfan
3.2mg/kg/day iv. for 2-4 days
TBI
2Gy twice daily for 1 day
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)

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

years-old

Age-upper limit

years-old

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
1.Patients who do not have an available HLA-matched or one locus-mismatched related donor.
2.Patients who have a two- or three-locus-mismatched haploidentical related donor in good condition. (This donor should precede an HLA-matched or one locus-mismatched related donor accoridng to the disease status.)
3.Patients who do not have an HLA-matched or one allele-mismatched unrelated donor, or patients whose disease status preclude time-consuming donor coordination.
4.Patients with high-risk acute leukemia, advanced CML, refractory malignant lymphoma, advanced MDS, acute or lymphoma type ATLL, or refractory severe aplastic anemia.
5.Patients who are 20 to 65 years old
6.Patients in performance status of 0 or 1.
7.Patients whose major organ functions are preserved.

Key exclusion criteria

Exclusion criteria
1.Patients with poorly controlled active infection.
2.Patients with coexistence of malignancy.
3.Patients who are pregnant or nursing.
4.Patients with serious mental disorder.
5.Patients with HIV antibody positive.
6.Patients who are allergic to drugs used in conditioning regimen or GVHD prophylaxis.

Target sample size

Research contact person

Name of lead principal investigator

1st name	Yoshinobu
Middle name
Last name	Kanda

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

330-8503

Address

1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan

TEL

0486472111

Email

shinichikako@asahi-net.email.ne.jp

Public contact

Name of contact person

1st name	Shinichi
Middle name
Last name	Kako

Organization

Saitama Medical Center, Jichi Medical University

Division name

Division of Hematology

Zip code

330-8503

Address

1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan

TEL

0486472111

Homepage URL

Email

shinichikako@asahi-net.email.ne.jp

Sponsor
Institute	Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization	Grant-in-Aid from the Ministry of Health, Labor and Welfare of Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	institutional review board of Jichi Medical University Saitama Medical Center
Address	1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
Tel	048-647-2111
Email	yanaiakr@jichi.ac.jp

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

2012

Year

Month

Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000009310
Publication of results	Published

Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/ejh.13204?af=R

Number of participants that the trial has enrolled

Results

The primary outcome
measure was the survival rate with the engraftment of donor cells and without
grade III-IV acute graft-vs-host disease (GVHD) at 60 days after transplantation.The primary outcome measure was achieved in 86% of the patients.

Results date posted

2019

Year

Month

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

adult patients with advanced hematological malignancy

Participant flow

one-arm study; patients participated from a single institution

Adverse events

Non-relapse death was observed in three patients,
and all of them had a history of previous allogeneic HSCT.

Outcome measures

the survival rate with the engraftment of donor cells and without
grade III-IV acute graft-vs-host disease (GVHD) at 60 days after transplantation

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2012

Year

Month

Day

Date of IRB

2012

Year

Month

Day

Anticipated trial start date

2012

Year

Month

Day

Last follow-up date

2016

Year

Month

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other
Other related information

Management information

Registered date

2012

Year

Month

Day

Last modified on

2019

Year

Month

Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009310