UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028831 |
|---|---|
| Receipt number | R000032973 |
| Scientific Title | Upfront autologous stem cell transplantation for primaly peripheral T cell lymphoma |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/11/12 11:00:18 |
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Basic information
Public title
Upfront autologous stem cell transplantation for primaly peripheral T cell lymphoma
Acronym
Upfront ASCT for primary PTCL
Scientific Title
Upfront autologous stem cell transplantation for primaly peripheral T cell lymphoma
Scientific Title:Acronym
Upfront ASCT for primary PTCL
Region
| Japan |
Condition
Condition
ALK-ngative Anaplastic large cell lymphoma(ALCL), Angioimmunoblastic T-cell lymphoma(AITL), Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effectveness of upfront ASCT for PTCL ptients were reported in the previous studies. However, the evidence based standard therapy has not been established. The aim of this study is to clear the safety and efficacy of high dose chemotheapy with upfront ASCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival at 1 year after ASCT
Key secondary outcomes
Overall survival at 2 years afer ASCT
Overall response rate at day 100 after ASCT
Adverse Events and treatment related mortality at day 100 afer ASCT
engraftment ratio and hematopoetic recovery at day 50 after ASCT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
The schedules of LEED therapy and the following ASCT were defined. Other supportive therapies were not defined. The conditioning regimen LEED consisted of CPA(60mg/kg once daily from day minus 4 and minus 3), VP16(500 mg/m2/day from day minus 4 to minus 2), L-PAM(130 mg/m2 once daily on day minus 1), and dexamethasone(40 mg/day from day minus 4 to minus 1). Autologous stem cells were infused on day 0.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ECOG PS 0 to 2
Fitst time ASCT
Completed autologous stem cell harvest
CR or PR afer first line chemotherapy
Resistration after written informed consent
Key exclusion criteria
Patients with uncontroled DM even by the usage of insulin
Patients with uncontroled HT
Patients with past histories of myocardial infarction, congestive heart failure, and unstable angina
Patients with the Ejection Frction less than 50 percent
Patients with active double cacer
Patients with active infection
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kajiguchi |
Organization
Tosei General Hospital
Division name
Hematology and Oncology
Zip code
Address
Nishioiwake-chou 160 Seto Aichi pre
TEL
0561-82-5101
kajiguchit@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Miyao |
Organization
Tosei General Hospital
Division name
Hematology and Oncology
Zip code
Address
Nishioiwake-chou 160 Seto Aichi pre
TEL
0561-82-5101
Homepage URL
koutarou380@yahoo.co.jp
Sponsor or person
Institute
Tosei General Hospital
Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
no
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 | 09 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | 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 | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032973
