UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010338 |
|---|---|
| Receipt number | 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 12:10:32 |
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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
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
sakurai821019@aol.com
Sponsor or person
Institute
Division of Hematology, Department of Internal Medicine, Keio University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008558
