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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020997
Receipt No. R000024227
Scientific Title Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Date of disclosure of the study information 2016/04/01
Last modified on 2019/08/21

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Basic information
Public title Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Acronym Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Scientific Title Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Scientific Title:Acronym Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Survival rate with neutrophil engraftment on day 28 after transplantation
Key secondary outcomes

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 1. Intra-bone infusion of cord blood cells
2. Any preconditioning including both myeloablative and non-myeloablative regimens are allowed
3. Any GVHD prophylaxis except in vivo T cell depletion are allowed
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 1. Hematological malignancy
2. Age: 16 yr or older
3. Performance status (ECOG): 0 to 2
4. Cord blood unit: HLA-A, B, DR serotypes 4/6 match, total nuclear cell count at 2.0 x 10e7/kg or higher, prioritize cord blood unit containing more CD34 positive cells, and prioritize cord blood unit without HLA corresponding to HLA antibody in patient serum
5. Neither uncontrolled heart failure nor uncontrolled ECG abnormality
6. No need for oxygen administration
7. AST: less than 5 x ULN, ALT: less than 5 x ULN, T-Bil: less than 3 x ULN
8. Cre: less than 3 x ULN
9. Patient's agreement to participate in this study
Key exclusion criteria 1. Positive for HBs-Ag, HCV-Ab, or HIV-Ab
2. In pregnancy or breast-feeding
3. Double cancer
4. Uncontrolled psychiatric disorder
5. Uncontrolled infectious disease
6. Allergy to drugs for transplant preconditioning or GVHD prophylaxis
7. Re-transplantation within 6 months from the preceding transplantation
8. Doctor's decision
Target sample size 65

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 Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa, 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 Tetsuya Nishida
Organization Nagoya University Graduate School of Medicine
Division name Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL 052-744-2145
Homepage URL
Email tnishida@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 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 名古屋大学医学部附属病院(愛知県)
兵庫医科大学病院(兵庫県)
岡山大学病院(岡山県)
新潟大学医歯学総合病院(新潟県)
東北大学病院(宮城県)
北海道大学病院(北海道)
川崎医科大学附属病院(岡山県)
安城更生病院(愛知県)
静岡県立静岡がんセンター(静岡県)
都立駒込病院(東京都)
島根大学医学部附属病院(島根県)
成田赤十字病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 12 Day
Date of IRB
2016 Year 04 Month 12 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 12 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024227

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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