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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007723
Receipt No. R000008620
Scientific Title Phase 1 safety trial of bortezomib-based graft-versus-host disease prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in the Japan marrow donor program (JMDP)
Date of disclosure of the study information 2012/04/15
Last modified on 2019/03/31

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Basic information
Public title Phase 1 safety trial of bortezomib-based graft-versus-host disease prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in the Japan marrow donor program (JMDP)
Acronym Safety of bortezomib-based GVHD prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in Japan
Scientific Title Phase 1 safety trial of bortezomib-based graft-versus-host disease prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in the Japan marrow donor program (JMDP)
Scientific Title:Acronym Safety of bortezomib-based GVHD prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in Japan
Region
Japan

Condition
Condition Adult hematological malignancies who have an indication for allogeneic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study safety of bortezomib-based GVHD prophylaxis after allogeneic stem cell transplantation from an HLA-mismatched unrelated donor for adult patients with hematological malignancy who lack a suitable donor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidences of dose-limiting toxicity of high-dose bortezomib (defined as DLT1) and low-dose bortezomib (defined as DLT2)
Key secondary outcomes

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
Medicine
Interventions/Control_1 Bortezomib is given at day 1, 4 and 7 after transplantation for GVHD prophylaxis. Three dose levels are planned (level 0: 1.0 mg/m2, level1: 1.3 mg/m2 and level2: 1.5 mg/m2) and 1.3mg/m2 (level 1) is started as the initial dose. The dose level is adjusted according to the rate of DLT. Tacrolimus is started as a 24-hour continuous intravenous infusion at a dose of 0.03 mg/kg/day from day -1. Methotrexate is given at day 1, 3, 6 and 11 after 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
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Documented informed consent
2. PS 0 or 1
3. Patient with hematological malignancy who have an indication for allogeneic hematopoietic stem cell transplantation but lacks a suitable donor including related HLA-matched, related 1-antigen mismatched and unrelated HLA-matched donor, and both of the following two conditions 3-1 and 3-2 should be met.
3-1: Single antigen mismatch at HLA-A, B, C or DR locus (with 7/8 allele match), or single allele mismatch at HLA-A or B locus (with 7/8 allele match). Only one antigen or one allele mismatch at HLA-C locus except for severe acute GVHD high-risk mismatch combination is excluded.
3-2: One antigen and one allele mismatch at HLA-A, B, C or DR (with 6/8 allele match) except for mismatches at the same locus.
4. Normal function of major organ
Key exclusion criteria 1. Uncontrolled active infection
2. Uncontrolled CNS invasion
3. Poorly controlled insulin-treated diabetes mellitus
4. Poorly controlled hypertension
5. Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last 3 months, liver cirrhosis or interstitial pneumonia
6. Pregnant, nursing or possibly pregnant woman
7. Patients with severe mental disorder who are unlikely to unable to participate in the study due to a severe mental disorder
8. A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant
9. HIV antibody positivity
10. Peripheral neuropathy >= grade2
11. Unable to give methotrexate due to pleural effusion and ascites
12. ATG or Campath-1H containing conditioning regimen
13. Nonmyeloablative conditioning regimens, the dose intensity of which are equal to or less than that of truly mini-conditioning developed in Seattle "TBI2Gy + Fludarabine 90mg/m2"
14. Progression or relapse is expected within day 100 after transplantation
15. Other active malignancy
16. Patients with a donor-specific anti-HLA antibodyies
17. Inappropriate to participate in this study as no indication for this study judged by physician in charge.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Nakane
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Email nakane@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiko Nakane
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Homepage URL
Email nakane@med.osaka-cu.ac.jp

Sponsor
Institute Hematology,Osaka City University, Graduate School of Medicine
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
2012 Year 04 Month 15 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 Completed
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
2012 Year 02 Month 01 Day
Anticipated trial start date
2012 Year 10 Month 16 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 10 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008620

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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