UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015694 |
|---|---|
| Receipt number | R000018240 |
| Scientific Title | Safety and efficacy of haploidentical hematopoietic stem-cell transplantation followed by post-transplant high-dose cyclophosphamide (RIC) |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/01/23 22:59:43 |
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Basic information
Public title
Safety and efficacy of haploidentical hematopoietic stem-cell transplantation followed by post-transplant high-dose cyclophosphamide (RIC)
Acronym
Tsukuba-Haplo RIC
Scientific Title
Safety and efficacy of haploidentical hematopoietic stem-cell transplantation followed by post-transplant high-dose cyclophosphamide (RIC)
Scientific Title:Acronym
Tsukuba-Haplo RIC
Region
| Japan |
Condition
Condition
hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of haploidentical hematopoietic stem-cell transplantation with reduced-intensity conditioning and post-transplant high-dose cyclophosphamide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
disease-free survival on day 100
Key secondary outcomes
overall survival, nonrelapse mortality, GVHD and relapse.
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
HLA-haploidentical hematopoietic stem-cell transplantation
post-transplant high-dose cyclophosphamide
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
1) Patients with hematological malignancy
2) Patients 16 to 65 years of age
3) Patients who do not have HLA antigen-matched (6/6) appropriate related donors
4) Patients who do not have HLA allele-matched (8/8) unrelated donors.
5) Patients with ECOG of 0, 1, or 2
6) Patients without severe dysfunction in the heart, the lung, the liver, and the kidney
7) Patients who gave written informed consent
Key exclusion criteria
1) Patients with anti-HLA antibody
2) Patients with uncontrollable psychological complications
3) Patients with active double cancer
4) Patients with uncontrollable active infection
5) Pregnant women
6) Patients who are judged inappropriate by investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Chiba |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
305-8575
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-3127
schiba-tky@umin.net
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Kurita |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
305-8575
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-3127
Homepage URL
n-kurita@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba, Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
IRB, University of Tsukba
Address
Amakubo 2-1-1, Tsukuba, Ibaraki
Tel
029-853-3914
chiken@un.tsukuba.ac.jp
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
| 2015 | Year | 01 | 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
10
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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
