UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028779 |
|---|---|
| Receipt number | R000032937 |
| Scientific Title | Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2024/08/27 13:59:31 |
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Basic information
Public title
Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide
Acronym
Tsukuba PTCY for MRD/MUD
Scientific Title
Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide
Scientific Title:Acronym
Tsukuba PTCY for MRD/MUD
Region
| Japan |
Condition
Condition
AML, ALL, NHL. MDS
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of HSCT from MRD/MUD using post-transplant cyclophosphamide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Success rate at 6 months.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50 mg/kg of cyclophosphamide on day 3, 4
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) AML, ALL, NHL, MDS
2) age 16-60
3) PS =< 2
4) EF >= 40%
5) SpO2 >= 90%
6) Bil =< 2.0 mg/dl
7) Ccr >= 30 ml/min
Key exclusion criteria
1) positive for HBs Ag
2) positive for HIV Ag
3) depression
4) pregnancy
5) coexisting active cancer
6) active infection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chiba |
| Middle name | |
| Last name | Chigeru |
Organization
University of Tsukuba
Division name
Department of Hematology, Faculty of Medicine
Zip code
3058575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
029-853-3127
schiba-tky@umin.net
Public contact
Name of contact person
| 1st name | Kurita |
| Middle name | |
| Last name | Naok |
Organization
University of Tsukuba
Division name
Department of Hematology, Faculty of Medicine
Zip code
3058575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
029-853-3127
Homepage URL
kuripon@mvb.biglobe.ne.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032937
