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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000865
Receipt No. R000001039
Scientific Title Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Date of disclosure of the study information 2007/10/24
Last modified on 2018/01/31

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Basic information
Public title Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Acronym Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Scientific Title Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Scientific Title:Acronym Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Region
Japan

Condition
Condition Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult patients with hematological malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Probability of survival with engraftment at 60 days post-transplant
Key secondary outcomes Adverse events related to intra-bone-marrow injection, term to hematopoietic recovery, treatment-associated toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, transplant-related mortality, relapse rate, disease-free survival, overall survival, causes of death

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
Maneuver
Interventions/Control_1 Reduced-intensity conditioning followed byintra-bone-marrow cord blood transplantation
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All of the following are required. (1)Adult patients with hematological malignancy who need allogeneic transplantation (2)Any of the following is required. 1.Age 55 or older 2.Patients with Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI) of one or more between 16 and 55 years old 3.A prior history of hematopoietic stem cell transplantation (3)No suitable donor is available except unrelated cord blood. (4)Marrow blasts less than 70% (5)Written informed consent to participate the trial. (6)Performance status(ECOG) 0 or 1 (7)A cord blood unit matched at >4 of 6 HLA antigens (A, B, DR) and with cryopreserved total nucleated cell dose of >2 x 10E7/kg is available.
Key exclusion criteria Any of the following. (1)Positive for HIV antibody or HBs antigen or HCV antibody (2)Patients treated with gemtuzumab ozogamicin within 6 months (3)Pregnant or during breast feeding (4)Patients with other malignant comorbidity (5)Uncontrolled psychiatric disease (6)Uncontrolled active infection (7)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (8)Impaired organ function (a)left ventricular ejection fraction smaller than 40% (b)FEV1.0 and TLC less than 30% (c)AST or ALT over 5xULN(NCI-CTCAE Grade 3) (d)serum creatinine over 3xULN(NCI-CTCAE Grade 3) (9)Re-transplant within 1 year from the previous transplantation (10)Cases that physicians judged as inappropriate.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Murata
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Email mmurata@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Murata
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Homepage URL
Email mmurata@med.nagoya-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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 名古屋大学医学部附属病院(愛知県)、金沢大学医学部附属病院(石川県)、岡山大学病院(岡山県)、新潟大学医歯学総合病院(新潟県)、北海道大学病院(北海道)、東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2007 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28582607
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
2007 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2016 Year 07 Month 26 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2017 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 10 Month 24 Day
Last modified on
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001039

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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