UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021783 |
|---|---|
| Receipt number | R000025124 |
| Scientific Title | A prospective study which assess the safety and efficiacy of haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma |
| Date of disclosure of the study information | 2016/04/05 |
| Last modified on | 2016/04/05 14:26:55 |
* 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
A prospective study which assess the safety and efficiacy of haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
Acronym
Haplo for ATL
Scientific Title
A prospective study which assess the safety and efficiacy of haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
Scientific Title:Acronym
Haplo for ATL
Region
| Japan |
Condition
Condition
aggressive adult T cell leukemia/lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the safety and efficacy of haploidentical hematopoietic stem cell transplantation using posttransplantation cyclophosphamide and reduced-intensity conditioning regimen for ATL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Survival at day 60 after transplantation with engraftment and without grade III-IV acute GVHD
Key secondary outcomes
(1) 1-year OS/PFS
(2) 1-year NRM
(3) graft failure
(4) time to engraftment, complete chimerism
(5) acute/chronic GVHD
(6) regimen-related toxicity CTCAE ver 4.0
(7) relapse rate
(8) incidence of bacterial, fungal, viral infection
(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 hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
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
Patients are considered eligible when all criteria are met
(1) acute or lymphoma type
(2) no HLA identical or HLA 1 locus-mismatched related or unrelated donor, or need urgent HSCT
(3) HLA haploidentical related donor is available
(4) age: 18-65
(5) ECOG PS 0 or 1
(6) disease status: CR, PR, SD
(7) written consent is obtained
(8) are expected to survive at least 3 months or longer
Key exclusion criteria
Patients who meet any criteria below are ineligible
(1) severe organ failure
(2) uncontrolled hypertension
(3) HIV infection
(4) uncontrolled infection
(5) uncontrolled CNS invasion
(6) pregnant/lactating
(7) psychological disorder
(8) known allergy for drugs used as GVHD prophylaxis or conditioning regimen
(9) history of administration of anti-CCR4 antibody
(10) high titer of anti-donor specific HLA antibody
(11) the physician considers inappropriate for this study
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Fukuda |
Organization
National Cancer Center Hospital
Division name
Department of hematopoietic stem cell transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tafukuda@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
National Cancer Center Hospital
Division name
Department of hematopoietic stem cell transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
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
AMED
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 05 | 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
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | 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
| 2016 | Year | 04 | Month | 05 | Day |
Last modified on
| 2016 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025124
