UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022819 |
|---|---|
| Receipt number | R000026302 |
| Scientific Title | Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16) |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2017/01/06 09:13:00 |
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Basic information
Public title
Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)
Acronym
FBMTG MOG16
Scientific Title
Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)
Scientific Title:Acronym
FBMTG MOG16
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
Investigation of efficacy and safety on sequential combination of mogamulizumab after CHOP in patients with untreated primary adult T cell leukemia-lymphoma (ATL)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival (OS)
Key secondary outcomes
1. Progression-free survival (PFS) at 1 year point after initial treatment
2. Overall survival (OS) at 1 year point after initial treatment
3. Overall response rate (ORR)
4. ORR according to lesion
5. Complete response rate
6. Evaluation of safety: occurrence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mogamulizumab is administered 8 times at the dose of 1mg/kg in every 2 weeks after 3 courses of CHOP-21 chemotherapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with untreated primary ATL nonadaptive for transplantation (diagnosed by HTLV-1 antibody positive, hemocytologically/ histopathologically and surface character)
2) Patients with serum anti HTLV-1 antibody positive.
3) Patients with any of acute type, lymphoma type or chronic type with prognosis decision factor in ATL disease type categories.
4) Patients with more than 20 years old at the enrollment date.
5) Patients with performance status (ECOG) 0 - 2.
6) Patients with measurable lesion in Response Evaluation criteria of ATL (JCOG version).
7) Patients have met the following all latest clinical test standards within 14 days prior to enrollment (eligible on the same day of the last week of the enrollment day)
(1) Serum creatinine: < 2.0mg/dL (eligible in the case of neoplastic increase)
(2) AST, ALT, ALP: < 2.5 times of upper limit of normal.
(3) Total bilirubin < 2.0mg/dL
8) Patients providing the written informed consent.
Key exclusion criteria
1) Patients with uncontrollable diabetes mellitus.
2) Patients with uncontrollable hypertension.
3) Patients with uncontrollable autoimmune disease.
4) Patients with severe skin disorder other than ATL lesion.
5) Patients with anamnesis of myocardial infarction and congestive heart failure, and complication of unstable angina.
6) Patients with less than 50% of resting ejection fraction in echocardiography and nuclear medical scan.
7) Patients with active double cancer.
8) Patients with uncontrollable active infection.
9) Patients with central nervous infiltration.
10) Patients with HIV antibody positive or HBs antigen positive.
11) Patients with complication of mental disease or psychiatric symptom.
12) Patients with pregnancy or possibility of pregnancy and patients with nursing.
13) Patients judged by the investigator to be inappropriate for study participation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyushu University Graduate school of Medicine
Division name
Department of Medicine and Biosystemic Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Kato |
Organization
Kyushu University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
Homepage URL
kojikato@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Cooperative research with Fukuoka Blood & Marrow Transplant Group and CReS Kyushu
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 27 | 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
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026302
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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