UMIN-CTR Clinical Trial

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

Adult T-cell leukemia-lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

akashi@med.kyushu-u.ac.jp

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

Email

kojikato@intmed1.med.kyushu-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Kyowa Hakko Kirin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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