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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028831
Receipt No. 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

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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
Email 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
Email koutarou380@yahoo.co.jp

Sponsor
Institute Tosei General Hospital
Department of Hematology and Oncology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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