UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011004 |
|---|---|
| Receipt number | R000012877 |
| Scientific Title | Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin (RIC version) Phase I |
| Date of disclosure of the study information | 2013/06/20 |
| Last modified on | 2018/10/31 16:50:50 |
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Basic information
Public title
Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
(RIC version)
Phase I
Acronym
Post-haploSCT CY protocol (RIC version)
Scientific Title
Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
(RIC version)
Phase I
Scientific Title:Acronym
Post-haploSCT CY protocol (RIC version)
Region
| Japan |
Condition
Condition
Hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To optimize the dose of ATG-G in haploidentical HSCT using posttransplant CY in combination with RIC
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Day 60 survival with engraftment without grade III-IV acute GVHD
Key secondary outcomes
(1) 1-year OS and PFS
(2) 1-year NRM
(3) graft failure
(4) time to engraftment and complete donor chimerism
(5) acute/chronic GVHD
(6) regimen-related toxicity (CTCAE ver 4.0)
(7) relapse
(8) infection (bacterial, fungal, viral)
(9) immune reconstitution
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
Haploidentical HSCT with a RIC regimen using posttransplant CY as 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) high-risk hematological malignancy
(2) patients who do not have an HLA matched related donor or unrelated donor
(3) patients who have an HLA haploidentical related donor
(4) Age: >=18, <=65 years old
(5) ECOG PS 0 or 1
(6) patients with informed consent
(7) patients who are expected to survival at least 3 months
(8) patients who are ineligible for a myeloablative conditioning regimen
Key exclusion criteria
(1) severe organ dysfunction
(2) uncontrolled hypertenstion
(3) HIV
(4) uncontrolled active infection
(5) uncontrolled CNS disease
(6) pregnant
(7) uncontrolled mental disorder
(8) allergy to drugs used as conditioning regimen or GVHD prophylaxis
(9) recent high-dose chemotherapy
(10) patients whom the physician regard as inappropriate for this study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Hematopoietic Cell Transplantation Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
sfuji@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Hematopoietic Cell Transplantation Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
sfuji@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 20 | 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
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012877
