UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019357 |
|---|---|
| Receipt number | R000022303 |
| Scientific Title | A phase II trial of CHOP-14 with Mogamulizumab for untreated elderly patients with CCR4 positive adult T-cell leukemia/lymphoma |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2022/08/22 09:34:59 |
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Basic information
Public title
A phase II trial of CHOP-14 with Mogamulizumab for untreated elderly patients with CCR4 positive adult T-cell leukemia/lymphoma
Acronym
Moga-CHOP-14
Scientific Title
A phase II trial of CHOP-14 with Mogamulizumab for untreated elderly patients with CCR4 positive adult T-cell leukemia/lymphoma
Scientific Title:Acronym
Moga-CHOP-14
Region
| Japan |
Condition
Condition
Adult T-cell leukemia lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of CHOP-14 with Mogamulizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1 year progression free survival
Key secondary outcomes
complete response rate
response rate
overall survival
1 year event free survival
adverse events
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
Mogamulizumab
1mg/kg, every 2 weeks (with CHOP-14) 6+2cycles
CHOP (every 2 weeks) 6 cycles
CPA 750mg/m2 div Day 1
DXR 50mg/m2 div Day 1
VCR 1.4mg/m2 (max 2.0mg) iv Day 1
PSL 40mg/m2 po Day 1, 2, 3, 4, 5
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
| 66 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following are eligible.
1) Cytologically or pathologically proven peripheral T-cell malignancy with positivity for anti-HTLV-1 antibody.
2) ATL in acute type, lymphoma type, or chronic type with unfavorable prognostic factors.
3) Positive for CCR4 antigen by flow cytometry or immunehistochemistry.
4) Aged over 66 years old or between 56 and 65years old if the patients do not want to receive allogeneic stem cell transplantation.
5) ECOG PS 0-3, or PS 4 with hypercalcemia.
6) No previous anti-cancer treatment, except for interferon and antiretroviral treatment. Steroids should be discontinuation until registration.
7) Meet all of the following
i) neutrophil=>1,500/mm3
(neu=>500/mm3 with bone marrow involvement)
ii) Platelet=>10.0x104/mm3
(PLT 2.0x104/mm3 with bone marrow involvement)
iii) GOT(AST)=>150 U/L
(GOT(AST)=<300 U/L with Liver involvement)
iv) male : GPT(ALT)=<210 U/L
female : GPT(ALT)=<115 U/L
(male : GPT(ALT)=<420 U/L, female : GPT(ALT)=<230 U/L with liver involvemnet)
v) T.Bil=<2.0mg/dL (T.Bil=<5.0mg/dL with liver involvement)
vi) serum creatinine=<1.6mg/dL(male), 1.2mg/dL (female)
vii) SpO2=>92% (room air)
(SpO2=>90% (room air) with lung involvement)
viii) Normal ECG
ix) Ejection fraction=>50% by UCG
8) Written informed consent.
Key exclusion criteria
1) CNS disease
2) Complication of coronary disease, cardiomyopathy, cardiac failure, or arrhythmia requiring medical
intervention.
3) Diabetes mellitus uncontrolled by administration of insulin
4) HBs-Ag positive
5) HCV-Ab positive
6) HIV-Ab positive
7) Liver cirrhosis
8) Complication of interstitial pneumonia or pulmonary fibrosis requiring oxygen administration
9) Synchronous or metachronous malignancy
10) Autoimmune disease
11) Pregnant or lactating women
12) Psychiatric disease
13) History of hypersensitivity to any of the components of the formulation in POTELIGEO.
14) Patients who are considered to be unsuitable for enrollment by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishitsuka |
Organization
KAGOSHIMA UNIVERSITY Graduate School of Medical and Dental Sciences
Division name
Division of Hematology and Immunology
Zip code
890-8544
Address
8-35-1 Sakuragaoka Kagoshima-city, Kagoshima 890-8544, Japan
TEL
099-275-5934
kenji-i@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ilseung |
| Middle name | |
| Last name | Choi |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hematology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka-city Fukuoka 811-1395, Japan
TEL
092-541-3231
Homepage URL
choi.ilseung.yc@mail.hosp.go.jp
Sponsor or person
Institute
KAGOSHIMA UNIVERSITY Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital Clinical Research Review board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya City
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs041180130
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
今村総合病院（鹿児島県）
大分県立病院（大分県）
日本赤十字社長崎原爆病院（長崎県）
佐世保市総合医療センター（長崎県）
国立病院機構 熊本医療センター（熊本県）
熊本大学医学部附属病院（熊本県）
大分大学医学部附属病院（大分県）
長崎大学病院（長崎県）
福岡大学病院（福岡県）
鹿児島大学病院（鹿児島県）
岩手医科大学附属病院（岩手県）
国立病院機構 長崎医療センター（長崎県）
宮崎大学医学部附属病院（宮崎県）
和歌山県立医科大学附属病院（和歌山県）
国立病院機構 鹿児島医療センター（鹿児島県）
近畿大学病院（大阪府）
国立病院機構 北海道がんセンター（北海道）
くまもと森都総合病院（熊本県）
JR大阪鉄道病院（大阪府）
札幌北楡病院（北海道）
名古屋市立大学病院（愛知県）
中頭病院（沖縄県）
ハートライフ病院（沖縄県）
国立病院機構 九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 19 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022303
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