UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of steroid maintenance therapy in angioimmunoblastic T cell lymphoma
Title of the study (Brief title)	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	Masatoshi Sakurai
Organization	Keio University of Medicine
Division name	Division of Hematology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3785
Email	sakurai821019@aol.com

Public contact
Name of contact person	Masatoshi Sakurai
Organization	Keio University of Medicine
Division name	Division of Hematology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 20 Day
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

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Publication of results	Unpublished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