UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Upfront autologous stem cell transplantation for primaly peripheral T cell lymphoma
Title of the study (Brief title)	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	Tomohiro Kajiguchi
Organization	Tosei General Hospital
Division name	Hematology and Oncology
Address	Nishioiwake-chou 160 Seto Aichi pre
TEL	0561-82-5101
Email	kajiguchit@gmail.com

Public contact
Name of contact person	Kotaro Miyao
Organization	Tosei General Hospital
Division name	Hematology and Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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