UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020997 |
|---|---|
| Receipt number | 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 18:23:45 |
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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
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
tnishida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024227
