UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012268 |
|---|---|
| Receipt number | R000014345 |
| Scientific Title | Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL) |
| Date of disclosure of the study information | 2013/11/11 |
| Last modified on | 2016/05/13 15:07:37 |
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Basic information
Public title
Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)
Acronym
Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)
Scientific Title
Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)
Scientific Title:Acronym
Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)
Region
| Japan |
Condition
Condition
Adult T cell leukemia/lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess efficacy and safety of arsenic trioxide/interferon/zidovudine combined with conventional chemotherapy for patients with adult T cell leukemia/lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Three year overall survival
Key secondary outcomes
CR rate, CR+PR rate, safety
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
Conventional chemothrapy combined with arsenic trioxide/interferon/zidovudine
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
| 56 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathologically proven T cell lymphoma
2) Anti-HTLV-1 antibody positive, Southern blotting proven HTLV-1 provirus clonality
3) acute type/lymphoma type/chronic type with poor prognosis factors
4) Performance status (PS) 0-3
5) untreated ATL
6) Conserved main organ function
Key exclusion criteria
1) History of glaucoma
2) Poor control of diabetes mellitus
3) Coronary artery disease/cardiomyopathy/hear failure/arrhythmia
4) HIV antibody, HCV antibody, HBs antigen positive
5) Interstitial pneumonia, pulmonary fibrosis, severe emphysema
6) Acute hepatitis, chronic hepatitis, cirrhosis
7) Malignancy, malignant lymphoma, myelodysplastic syndrome, leukemia
8) Pregnancy
9) Psychological disease
10) History of allergy for arsenic trioxide/interferon/zidovudine
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomichi Arima |
Organization
Kagoshima University Hospital
Division name
Department of Hematology and Immunology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5934
nao@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Yoshimitsu |
Organization
Kagoshima University Hospital
Division name
Department of Hematology and Immunology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5934
Homepage URL
myoshimi@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Miyazaki Hospital, National Hospital Organization Kagoshima Medical center
Name of secondary funder(s)
None
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
鹿児島大学病院(鹿児島県)、宮崎大学医学部附属病院(宮崎県)、国立病院機構鹿児島医療センター(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 11 | 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
| 2013 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 11 | Day |
Last modified on
| 2016 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014345
