UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000865 |
|---|---|
| Receipt number | 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 19:10:19 |
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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
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
mmurata@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
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）、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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001039
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