UMIN-ICDS Clinical Trial

Public title

Observational study of ibrutinib in Japanese CLL patients treated in routine clinical practice

Acronym

CLL-Orbit Study

Scientific Title

Observational study of ibrutinib in Japanese CLL patients treated in routine clinical practice

Scientific Title:Acronym

CLL-Orbit Study

Region

Japan

Condition

chronic lymphocytic leukemia/ small lymphocytic lymphoma: CLL/ SLL

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To describe the longer-term clinical outcomes (e.g., 36-month PFS rate in 1L CLL population) of patients initiating ibrutinib as first-line treatment for CLL in routine practice in Japan.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

36-month PFS rate in 1L CLL population

Key secondary outcomes

To describe the longer-term clinical outcomes (e.g., Best Response (BR) ) of patients initiating ibrutinib treatment for 1L CLL in Japan
To describe the longer-term clinical outcomes (e.g., 36-month PFS rate, BR) of patients initiating ibrutinib treatment for RR CLL in Japan
To investigate how ibrutinib-treated CLL patients are managed in routine clinical practice in Japan (including specific prophylaxis and treatment modifications) - particularly those at risk of or experiencing specific AEs
To describe the characteristics of patients initiating ibrutinib as a first-line treatment for CLL in routine clinical practice in Japan
To describe the characteristics of patients initiating ibrutinib as a treatment for RR CLL in routine clinical practice in Japan

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Male or female patient aged at least 20 years of age at the time of ibrutinib initiation
2. Must have a confirmed diagnosis of CLL in accordance with local practice
3. Must have initiated ibrutinib for either 1L or RR CLL between 1 July 2018 and 31 December 2020 (inclusive) at the participating site
4. Patients whose consent to participate in this study has been obtained from the patient or the legally acceptable representative (However, if the Independent Ethics Committee/Institutional Review Board approves, including cases in which it is difficult to obtain consent from the patient or the legally acceptable representative due to death or other reasons, opt-out enrollment will be permitted.)

Key exclusion criteria

1. Patients who were treated with ibrutinib without following the instructions in the package insert
2. Must have a confirmed diagnosis of CLL in accordance with local practice
3. Must have initiated ibrutinib for either 1L or RR CLL between 1 July 2018 and 31 December 2020 (inclusive) at the participating site
4. Patients whose consent to participate in this study has been obtained from the patient or the legally acceptable representative (However, if the Independent Ethics Committee/Institutional Review Board approves, including cases in which it is difficult to obtain consent from the patient or the legally acceptable representative due to death or other reasons, opt-out enrollment will be permitted.)
5. Received an investigational drug or used an invasive investigational medical device within the period from the start date of the treatment through to cessation of ibrutinib. [Note: investigational treatments after progression from ibrutinib or discontinuation of ibrutinib are allowable]
6. Was enrolled in another Janssen-sponsored study (including post-marketing surveillance) between their initiation of ibrutinib and end of their data collection

Target sample size

200

Name of lead principal investigator

1st name	Ai
Middle name
Last name	Omi

Organization

Janssen Pharmaceutical K.K.

Division name

Medical Affairs Division

Zip code

101-0065

Address

5-2, Nishi-kanda 3-chome,Chiyoda-ku,Tokyo

TEL

03-4411-7700

Email

aomi@its.jnj.com

Name of contact person

1st name	Tsunekuni
Middle name
Last name	Kamiya

Organization

Janssen Pharmaceutical K.K.

Division name

Medical Affairs Division

Zip code

101-0065

Address

5-2, Nishi-kanda 3-chome,Chiyoda-ku,Tokyo

TEL

03-4411-7700

Homepage URL

Email

TKamiya4@ITS.JNJ.com

Institute

Janssen Pharmaceutical K.K.
Medical Affairs Division

Institute

Department

Personal name

Organization

Janssen Pharmaceutical K.K.
Medical Affairs Division

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Janssen Pharmaceutical K.K. Medical Affairs Division

Address

5-2, Nishi-kanda 3-chome,Chiyoda-ku,Tokyo

Tel

03-4411-7700

Email

awatan18@its.jnj.com

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

2022

Year

11

Month

07

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

No longer recruiting

Date of protocol fixation

2021

Year

01

Month

21

Day

Date of IRB

2022

Year

03

Month

31

Day

Anticipated trial start date

2023

Year

01

Month

01

Day

Last follow-up date

2023

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter, non-interventional, retrospective chart review study to describe the use of ibrutinib in patients with CLL in routine clinical practice in Japan. All patients who initiated ibrutinib for either 1L or RR CLL between 1 July 2018 and 31 December 2020 will be eligible for inclusion subject to meeting all other selection criteria.Data from ibrutinib initiation through to 31 December 2022 will be retrospectively extracted for each patient (the data collection period). The minimum follow-up duration for completing patients will be 24 months and the maximum follow-up duration will be 54 months. The end of patient follow-up will be the last data collection timepoint within the study, which will be 31 December 2022 at the latest. However, all data extraction will occur retrospectively (i.e., after this time).

Registered date

2022

Year

10

Month

20

Day

Last modified on

2024

Year

04

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056119