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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006529
Receipt No. R000005984
Scientific Title Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Date of disclosure of the study information 2011/10/12
Last modified on 2018/04/17

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Basic information
Public title Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Acronym Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Scientific Title Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Scientific Title:Acronym Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Region
Japan

Condition
Condition Refractory hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of Intra-bone marrow injection of cord blood following reduced-intensity conditioning
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of donor cell engraftment (>90% of donor origin)
Key secondary outcomes Incidence of severe GVHD
Incidence and severity of chronic GVHD
Disease free survival at 1 year after transplantation
Treatment related mortality within 1 year after transplantation
Incidence of infections (bacteria, fungus, virus, etc)
Immune reconstitution after transplantation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intra-bone marrow injection of unwashed cord blood following reduced-intensity conditioning
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Written informed consent.
2)Unavailability of HLA (A, B, DR)-matched or -one antigen mismatched-related donor.
3)Unavailability of HLA (A, B, DR)-matched or one allele of HLA-DRB1 mismatched-unrelated donor or needs urgent transplantation. 2) Patients aged between 35 and 55 years.
4)Patients aged between 55 and 70 years. Patients aged between 18 and 55 years who are not eligible for myeloablative conditioning.
5) Sufficient organ function
5-1) Ejection Fraction >= 50%
5-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit
5-3) serum creatinine level <= 1.5upper limit of institution
Key exclusion criteria 1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Patients who are considered as inappropriate with other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL 0798-45-6886
Email ogawah@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Okada
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL 0798-45-6886
Homepage URL
Email masaya@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科大学 血液内科

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 08 Month 23 Day
Date of closure to data entry
2016 Year 08 Month 23 Day
Date trial data considered complete
2016 Year 08 Month 23 Day
Date analysis concluded
2017 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 12 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005984

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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