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

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 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


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

Value
https://center6.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