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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000032036 |
Receipt No. | R000036552 |
Scientific Title | Prospective observational study of cord blood transplantation in NJHSG |
Date of disclosure of the study information | 2018/05/07 |
Last modified on | 2019/10/01 |
Basic information | ||
Public title | Prospective observational study of cord blood transplantation in NJHSG | |
Acronym | NJHSG-CBT18 | |
Scientific Title | Prospective observational study of cord blood transplantation in NJHSG | |
Scientific Title:Acronym | NJHSG-CBT18 | |
Region |
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Condition | |||
Condition | Acute leukemia, Myelodysplastic syndrome, Malignant lymphoma | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the clinical course and outcome of standard CBT in NJHSG, focusing on GVHD prophylaxis and its incidence. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The incidence of grade III-IV acute GVHD at 100 days |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patients who have hematologic malignancies as defined at least one of the following:
a) Acute Leukemia b) MDS/MPD c) Lymphoma, CR or chemosensitive PR 2.Age: over 20 years old. 3.Patients who have cord blood with following criteria a) Disclosed in Cord Blood Banks in Japan b) HLA, more than 4/6 matched c) NCC, more than 2.0X107/kg d) no DSA. 4.Patients who give written informed consent to participate in the study. |
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Key exclusion criteria | Patients who are not eligible for this study at the discretion of the investigator. | |||
Target sample size | 65 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido university hospital | ||||||
Division name | Department of hematology | ||||||
Zip code | |||||||
Address | Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan | ||||||
TEL | 011-706-7214 | ||||||
s.shiratori@med.hokudai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido university hospital | ||||||
Division name | Department of hematology | ||||||
Zip code | |||||||
Address | Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan | ||||||
TEL | 011-706-7214 | ||||||
Homepage URL | |||||||
s.shiratori@med.hokudai.ac.jp |
Sponsor | |
Institute | NJHSG |
Institute | |
Department |
Funding Source | |
Organization | NJHSG |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | 1. Transplantation-day100
1)Conditioning regimen 2)GVHD prophylaxis 3)Day of transplantation 4)NCC, CD34+ cell number 5)Engraftment 6)PIR,ES 7)HHV-6 encephalitis 8)Blood stream infection 9)oral mucositis 10)GVHD 11)Treatment for GVHD 12)Relapse 13)adverse events 14)Outcome 2. 1 year post CBT 1)cGVHD 2)Immunosuppressant 3)Relapse 4)Outcome 3. 2 year post CBT 1)cGVHD 2)Immunosuppressant 3)Relapse 4)Outcome |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036552 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |