UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)
Title of the study (Brief title)	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	Koichi Akashi
Organization	Kyushu University Graduate school of Medicine
Division name	Department of Medicine and Biosystemic Science
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5230
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	Koji Kato
Organization	Kyushu University Hospital
Division name	Department of Hematology and Oncology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5230
Homepage URL
Email	kojikato@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Cooperative research with Fukuoka Blood & Marrow Transplant Group and CReS Kyushu
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026302