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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009374
Receipt No. R000011010
Scientific Title Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study
Date of disclosure of the study information 2012/11/21
Last modified on 2018/10/31

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Basic information
Public title Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin
Phase I study
Acronym Post-CY haploHSCT with ATG (MAC)
Scientific Title Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin
Phase I study
Scientific Title:Acronym Post-CY haploHSCT with ATG (MAC)
Region
Japan

Condition
Condition hematological malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the dose of ATG-G in combination with posttransplant cyclophosphamide for haploidentical hematopoietic stem cell transplantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Day 60 engraftment and survival without grade III-IV acute GVHD
Key secondary outcomes (1) 1-year OS and PFS
(2) 1-year NRM
(3) graft failure
(4) engraftment rate
(5) acute and chronic GVHD
(6) regimen-related toxicity (CTCAE ver 4.0)
(7) relapse rate
(8) infectious disease
(9) immune reconstitution

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 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conditioning regimen and GVHD prophylaxis for allogeneic HSCT
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
18 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria (1) High risk hematological malignancy including AML, ALL, CML, HL, NHL, MDS
(2) Those who do not have HLA-matched or 1-locus mismatched related donor/unrelated donor
(3) Those who have HLA-haploidentical related donor
(4) Age >=18, <=55
(5) ECOG PS 0 or 1
(6) Those who agree to the participation
(7) Those who are expected to survive longer than 3 months
Key exclusion criteria (1) Organ dysfunction
(2) Uncontrolled hypertension
(3) HIV positive
(4) Uncontrolled active infection
(5) Uncontrolled CNS invasion
(6) Pregnant
(7) Psychiatric disorder
(8) Allergy to drugs used for HSCT
(9) Other reason which physicians think
the patient is inappropriate for the
study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Fuji
Organization National Cancer Center Hospital
Division name Division of Hematopoietic Stem Cell Transplantation
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email sfuji@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Fuji
Organization National Cancer Center Hospital
Division name Division of Hematopoietic Stem Cell Transplantation
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email sfuji@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
Address
Tel
Email

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 東京都中央区築地5-1-1

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 21 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
2012 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 21 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011010

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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