UMIN-CTR Clinical Trial

Public title

A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia

Acronym

A postmarketing all-case surveillance of mogamulizumab

Scientific Title

A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia

Scientific Title:Acronym

A postmarketing all-case surveillance of mogamulizumab

Region

Japan

Condition

CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of mogamulizumab in daily practice by
(1)detecting unknown adverse drug reactions (ADRs)
(2)understanding the occurrence status of ADRs
(3)capturing factors that are likely to affect safety and efficacy
(4)assessing priority survey items and other relevant matters.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

1.Safety
(1)Occurrence of ADRs (e.g., types and incidence)
(2)Evaluation on factors likely to affect safety
(3)Occurrence of serious adverse events
(4)Occurrence of priority survey items (infusion-related reactions, skin disorders, infections and immune disorders, and tumor lysis syndrome)
2.Efficacy
(1)Response rate (by attending physician)
(2)Survival rate at 31 weeks after treatment initiation

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

All patients who were treated with mogamuliumab, including mogamulizumab-retreated patients

Key exclusion criteria

None

Target sample size

300

Name of lead principal investigator

1st name	Kouichi
Middle name
Last name	Kawamura

Organization

Kyowa Kirin Co., Ltd.

Division name

Pharmacovigilance Department

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

03-5205-7200

Email

kouichi.kawamura.1r@kyowakirin.com

Name of contact person

1st name	Yukie
Middle name
Last name	Tsuji

Organization

Kyowa Kirin Co., Ltd.

Division name

Pharmacovigilance Department

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

03-5205-7200

Homepage URL

Email

yukie.tsuji.dq@kyowakirin.com

Institute

Kyowa Kirin Co., Ltd.

Institute

Department

Personal name

Organization

Kyowa Kirin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

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

12

Month

22

Day

URL releasing protocol

N/A

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.111

Number of participants that the trial has enrolled

597

Results

In the safety analysis population, adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion-related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]).
In the effectiveness analysis population, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months.

Results date posted

2020

Year

12

Month

07

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The majority of patients (93.8%) were of acute or lymphoma subtype, and in 30.8% of patients, mogamulizumab was used in combination with other modalities, mainly cytotoxic agents.
The median age of patients was 67.0 years, with patients aged over 70 years accounting for 41.6% of the population. Following mogamulizumab treatment, 49 patients (8.6%) underwent allogeneic HSCT, of which 47 were aged under 70 years. The median interval between the last mogamulizumab treatment and the HSCT was 36 days (range 6-191 days).
In the safety analysis population, the mean number of mogamulizumab administrations was 5.4, and 60% of patients did not complete all eight courses of mogamulizumab therapy, mainly due to disease progression (52.5%) and adverse events (37.0%).

Participant flow

Data were collected from all patients for whom mogamulizumab treatment was initiated from the launch on May 29, 2012 to before May 1, 2013, as daily clinical practice, and who had planned to be received intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, the approved dosing schedule in Japan, alone or in combination with other modalities. Patients were observed for 24 weeks after the last dose of mogamulizumab.

Adverse events

In the safety analysis population, 73.4% and 38.6% of patients were reported to experience at least one ADR and serious ADR, respectively. Of the 572 patients, ADRs in 42 patients (7.3%) resulted in death that was attributable to mostly infections (3.1% [18/572]) and graft vs host disease (GVHD; 1.2% [7/572]).
The most common ADRs were skin disorders (33.2%), IRRs (30.1%), and infections (22.0%), of which infections (14.7%) and skin disorders (10.8%) were the most common serious ADRs.

Outcome measures

The surveillance had five priority survey items for adverse events and adverse drug reactions (ADRs)-infusion-related reactions, skin disorders, infections, immune system disorders, and tumor lysis syndrome, which were determined as items to be collected intensively regardless of presence or absence of events, based on safety information from clinical studies.
The best overall response during mogamulizumab therapy and response at the end of mogamulizumab therapy were assessed by the attending physician according to the response criteria used in the phase 2 study in patients with relapsed ATL in Japan.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

04

Month

25

Day

Date of IRB

2012

Year

04

Month

23

Day

Anticipated trial start date

2012

Year

05

Month

29

Day

Last follow-up date

2014

Year

04

Month

30

Day

Date of closure to data entry

2018

Year

02

Month

23

Day

Date trial data considered complete

2018

Year

03

Month

29

Day

Date analysis concluded

2020

Year

06

Month

10

Day

Other related information

Surveillance following all-case surveillance method

Registered date

2016

Year

12

Month

22

Day

Last modified on

2020

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029207