UMIN-CTR Clinical Trial

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 Hiroyasu Middle name Last name Ogawa
Organization	Hyogo College of Medicine
Division name	Division of Hematology, Department of Internal Medicine
Zip code	663-8501
Address	1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL	0798-45-6886
Email	masaya@hyo-med.ac.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Okada
Organization	hyogo college of medicine
Division name	Division of Hematology, Department of Internal Medicine
Zip code	663-8501
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	Hyogo College of Medicine
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	Hyogo College of Medicine
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel	+81798456886
Email	masaya@hyo-med.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	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	2021 Year 06 Month 29 Day

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