UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001146 |
|---|---|
| Receipt number | R000001391 |
| Scientific Title | Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor |
| Date of disclosure of the study information | 2008/06/01 |
| Last modified on | 2015/10/13 16:41:31 |
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Basic information
Public title
Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor
Acronym
Phase II study with tacrolimus to prevent GVHD for reduced-intensity PBSCT from an HLA-identical related donor
Scientific Title
Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor
Scientific Title:Acronym
Phase II study with tacrolimus to prevent GVHD for reduced-intensity PBSCT from an HLA-identical related donor
Region
| Japan |
Condition
Condition
Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Adult T cell leukemia/lymphoma
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 tacrolimus to prevent acute GVHD after reduced-intensity PBSCT from an HLA-identical related donor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of grade II-IV acute GVHD at 100 days after PBSCT
Key secondary outcomes
Incidence of chronic GVHD, overall survival rate at 2 years, nonrelapse mortality rate at 2 years, relapse rate at 2 years, treatment-associated toxicity, term to hematopoietic recovery
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
| Medicine |
Interventions/Control_1
Use tacrolimus and short-term methotrexate as a GVHD prophylaxis
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the following are required. (1)Age between 16 and 65 (2)Patients receiving PBSCT from an HLA-A,B,DR matched related donor (3)Any of the following is required. 1.Age 40 or older 2.Patients with hematopoietic stem cell transplantation- specific comorbidity index (HCT-CI) of one or more (4)Adult patients with hematological malignancy who need allogeneic transplantation (acute leukemia, chronic leukemia, myelodysplastic syndrome, malignant lymphoma, adult T cell leukemia/lymphoma) (5)Performance status(ECOG) 0 - 2 (6)Written informed consent to participate this trial
Key exclusion criteria
(1)Positive for HIV antibody andor HBs antigen (2)T cell depleted transplantation (3)Pregnant or during breast feeding (4)Uncontrolled psychiatric disease (5)Uncontrolled active infection (6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen (7)A history of intravenous chemotherapy within 21 days before transplantation (8)Cases that physicians judged as inappropriate
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Miyamura |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of Hematology
Zip code
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya, Aichi, Japan
TEL
052-481-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Inamoto |
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
yinamoto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Blood and Marrow Transplantation Group
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | 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
| 2008 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001391
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