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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029947
Receipt No. R000034144
Scientific Title A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
Date of disclosure of the study information 2018/02/01
Last modified on 2018/05/11

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Basic information
Public title A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
Acronym CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming
Scientific Title A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
Scientific Title:Acronym CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming
Region
Japan

Condition
Condition Myelogenous Hematological Malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of granulocyte-colony-stimulating factor use with conditioning regimen for umbilical cord blood transplantation for adult myelogenous hematological malignancy patient. Conditioning regimen consists of a combination of cytarabine, cyclophosphamide, and total body irradiation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 2-year disease-free 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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To add G-CSF priming to the conditioning regimen concomittantly with two days of Ara-C.
Interventions/Control_2 Not to add G-CSF to the conditioning regimen.
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
55 years-old >=
Gender Male and Female
Key inclusion criteria 1.First stem cell transplantation including autologous or allogeneic.
2.Hematological disease listed below.
-Acute myelogenous leukemia
-Myelodysplastic syndrome, RAEB-1 or RAEB-2. Either intemediate-II or high in IPSS. High or very-high in WPSS. Relapsed after CR.
3.Obtained informed consent
4.Performance status 0,1,2
5.appropriate cord blood is available
6.appropriate organ function
Key exclusion criteria 1.HBs antigen positive
2.HCV antibody positive
3.HIV antibody positive
4 Donor-specific anti-HLA antibody positive
5.Use of gemtuzumab ozogamicin within 6 months before transplantation
6.During pregnant or breast-feeding
7. Uncontrollable psychiatric disorder
8. Uncontrollable infection
9. Allergy for any drug used in the conditioning regimen or GVHD-prophylaxis
10.Considered to be unfit for the study enrollment by the physician
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seitaro Terakura
Organization Nagoya University Hospital
Division name Deapartment of Hematology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Email tseit@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seitaro Terakura
Organization Nagoya University Hospital
Division name Department of Hematology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Homepage URL
Email tseit@med.nagoya-u.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 01 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
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 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
2017 Year 11 Month 13 Day
Last modified on
2018 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034144

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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