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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000359 |
Receipt No. | R000000457 |
Scientific Title | Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507) |
Date of disclosure of the study information | 2006/03/15 |
Last modified on | 2013/04/17 |
Basic information | ||
Public title | Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507) | |
Acronym | Double-unit cord blood transplantation(C-SHOT 0507) | |
Scientific Title | Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507) | |
Scientific Title:Acronym | Double-unit cord blood transplantation(C-SHOT 0507) | |
Region |
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Condition | ||
Condition | Hematological malignancies | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To study feasibility and effectiveness of double-unit cord blood transplantation |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Event-free survival at one year after double-unit cord blood transplantation |
Key secondary outcomes | Time of hematopoietic engraftment, treatment-related toxicity, incidence and severity of acute and chronic graft versus host disease, disease-free survival and overall survival at 1-year |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | To study feasibility and effectiveness of double-unit cord blood (CB) transplantation in patients with hematological malignancies requiring hematopoietic stem cell transplantation without any available single-unit CB. | ||
Interventions/Control_2 | |||
Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
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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) Patient with poor risk hematologic malignancies
2) Patient who receives double-unit CBT as first stem cell transplantation 3) Age: less than 55 years old 4) Patient without active infection at starting conditioning chemoradiatherapy 5) HIV-antibody negative patient 6) Patient who has no HLA-matched or one antigen-mismatched relatives 7) Patient who has no HLA-matched unrelated donor, or who requires urgent transplant even if he/she has HLA-matched unrelated donor 8) Patient who has no single CB unit with cell dose of more than 2.5x107/kg and 2 or more HLA antigen mismatches |
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Key exclusion criteria | 1) ECOG's performance status; 2 or more
2) Ejection fraction(EF); less than 50% 3) SaO2; more than 93% in room air 4) Serum creatinine; 1.3mg/dl or greater 5) Total bilirubin; 1.6mg/dl or greater, or GOT; 2 x normal value or greater 6) Down's syndrome 7) Fanconi's anemia |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | 1) Tokai University, School of Medicine
2) Hyogo College of Medicine |
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Division name | 1) Research Center for regenerative medicine 2) The Department of Transfusion Medicine | ||||||
Zip code | |||||||
Address | 1) Boseidai, Isehara-city, Kanagawa 2) 1-1,Mukogawa-cho,Nishinomiya,Hyogo | ||||||
TEL | 0463-93-1121 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Registry office of double-unit cord blood transplantation | ||||||
Division name | Research Center for regenerative medicine | ||||||
Zip code | |||||||
Address | Boseidai, Isehara-city, Kanagawa | ||||||
TEL | 0463-93-1121 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood. |
Institute | |
Department |
Funding Source | |
Organization | A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood. |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
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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=R000000457 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |