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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010338
Receipt No. R000008558
Scientific Title A prospective study of steroid maintenance therapy in angioimmunoblastic T cell lymphoma
Date of disclosure of the study information 2013/03/29
Last modified on 2016/11/11

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Basic information
Public title A prospective study of steroid maintenance therapy in angioimmunoblastic T cell lymphoma
Acronym Steroid maintenance therapy in AITL
Scientific Title A prospective study of steroid maintenance therapy in angioimmunoblastic T cell lymphoma
Scientific Title:Acronym Steroid maintenance therapy in AITL
Region
Japan

Condition
Condition Angioimmunoblastic T cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prospectively evaluate the efficacy of steroid maintenance therapy following a single course of CHOP therapy for previously untreated angioimmunoblastic T cell lymphoma. Prognostic factors using lymph node samples will also be assessed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year overall survival
Key secondary outcomes 1-year overall survival
1-year event-free survival
2-year event-free survival
Overall response rate
Time to treatment failure
Cumulative incidence of infection

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Following 1st course of CHOP therapy, PSL 0.5mg/kg/day was initiated from day 6 as maintenance therapy
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients previously untreated for AITL
Key exclusion criteria Patients with active malignancy other than lymphoma
Patients positive for HBs-Ag, HCV-Ab, HIV-Ab, HTLV-1-Ab
Patients with active tuberculosis infection
Patients that require antibiotecs therapy for infection
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Sakurai
Organization Keio University of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3785
Email sakurai821019@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Sakurai
Organization Keio University of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3785
Homepage URL
Email sakurai821019@aol.com

Sponsor
Institute Division of Hematology, Department of Internal Medicine, Keio University of Medicine
Institute
Department

Funding Source
Organization Novartis
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Eiju General Hospital, Keiyu Hospital, National Hospital Organaization Tokyo Medical Center, etc. All togather six hospitals
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 慶應義塾大学病院(東京都)、永寿総合病院(東京都)、けいゆう病院(神奈川県)、東京医療センター(東京都)、東京歯科大学市川総合病院(千葉県)、東京電力病院(東京都)、横浜市民病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 29 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
2011 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 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
2013 Year 03 Month 28 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008558

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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