UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007059 |
|---|---|
| Receipt number | R000008311 |
| Scientific Title | Phase II trial of combination therapy with arsenic trioxide and conventional chemotherapy for patients with relapsed or refractory adult T-cell leukemia (ATL) |
| Date of disclosure of the study information | 2012/01/12 |
| Last modified on | 2013/07/12 16:31:25 |
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Basic information
Public title
Phase II trial of combination therapy with arsenic trioxide and conventional chemotherapy for patients with relapsed or refractory adult T-cell leukemia (ATL)
Acronym
P-II for ATL with As and chemotherapy
Scientific Title
Phase II trial of combination therapy with arsenic trioxide and conventional chemotherapy for patients with relapsed or refractory adult T-cell leukemia (ATL)
Scientific Title:Acronym
P-II for ATL with As and chemotherapy
Region
| Japan |
Condition
Condition
Adult T-cell leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the treatment with the combination of As and chemotherapy for patients with ATL
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
adverse event incidence rate
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
1) arsenic trioxide (ATO) (0.15 mg/kg div. on days 1-5 of weeks 1)
2) RCM regimen, each cycle is 28 days
1)+2) is repeated 2 cycles.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Peripheral T-cell lymphoma diagnosed hematologically/pathologically and proven by FCM analysis.
2) HTLV-1 Ab positive.
3) acute, lymphoma and chronic type ATL with unfavorable factors
4) Aged 20 to 75 years old
5) Performance status (PS) of 0-3 on ECOG scale
6) Relapsed or refractory ATL patients after one or more prior lines of chemotherapy
7) Adequate hematological and major organ function
8) Written informed consent
9) more than 2 weeks of interval from last chemotherapy for ATL to scheduled first day of protocol treatment
Key exclusion criteria
1) history of glaucoma
2) uncontrollable DM (under insulin therapy)
3) treated cardiac disease, coronary artery disease, cardiomyopathy, heart failure and severe arrthythmia
4) HIV-Ab positive, HCV-Ab positive, HBs -Ag positive
5) interstitial pneumonia, pulmonary fibrosis, severe emphysema
6) acute hepatitis, chronic hepatitis, liver cirrhosis
7) synchronous or metachronous malignancy, history of malignant lymphoma, myelodysplastic syndrome and acute leukemia
8) pregnant or nursing women
9) psychological disturbance
10) hypersensitivity to arsenic trioxide
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | UOZUMI Kimiharu |
Organization
Kagoshima University Hospital
Division name
Dept. Hematology and Immunology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima City
TEL
099-275-5934
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | UOZUMI Kimiharu |
Organization
Kagoshima University Hospital
Division name
Dept. Hematology and Immunology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima City
TEL
099-275-5934
Homepage URL
uosakana@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital, Dept. Hematology and Immunology
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 12 | Day |
Last modified on
| 2013 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008311
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