UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009374 |
|---|---|
| Receipt number | R000011010 |
| Scientific Title | Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study |
| Date of disclosure of the study information | 2012/11/21 |
| Last modified on | 2018/10/31 16:50:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin
Phase I study
Acronym
Post-CY haploHSCT with ATG (MAC)
Scientific Title
Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin
Phase I study
Scientific Title:Acronym
Post-CY haploHSCT with ATG (MAC)
Region
| Japan |
Condition
Condition
hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the dose of ATG-G in combination with posttransplant cyclophosphamide for haploidentical hematopoietic stem cell transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Day 60 engraftment and survival without grade III-IV acute GVHD
Key secondary outcomes
(1) 1-year OS and PFS
(2) 1-year NRM
(3) graft failure
(4) engraftment rate
(5) acute and chronic GVHD
(6) regimen-related toxicity (CTCAE ver 4.0)
(7) relapse rate
(8) infectious disease
(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
Conditioning regimen and GVHD prophylaxis for allogeneic HSCT
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) High risk hematological malignancy including AML, ALL, CML, HL, NHL, MDS
(2) Those who do not have HLA-matched or 1-locus mismatched related donor/unrelated donor
(3) Those who have HLA-haploidentical related donor
(4) Age >=18, <=55
(5) ECOG PS 0 or 1
(6) Those who agree to the participation
(7) Those who are expected to survive longer than 3 months
Key exclusion criteria
(1) Organ dysfunction
(2) Uncontrolled hypertension
(3) HIV positive
(4) Uncontrolled active infection
(5) Uncontrolled CNS invasion
(6) Pregnant
(7) Psychiatric disorder
(8) Allergy to drugs used for HSCT
(9) Other reason which physicians think
the patient is inappropriate for the
study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Division of Hematopoietic Stem Cell Transplantation
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
Division of Hematopoietic Stem Cell Transplantation
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
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
東京都中央区築地5-1-1
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 21 | 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 | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 21 | 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
| 2012 | Year | 11 | Month | 21 | 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=R000011010
