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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001146
Receipt No. 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

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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
Email

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
Email yinamoto@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Blood and Marrow Transplantation Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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