UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032121
Receipt number R000036332
Scientific Title Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma
Date of disclosure of the study information 2018/04/10
Last modified on 2022/04/12 17:56:02

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Basic information

Public title

Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma

Acronym

Evaluation of therapeutic efficacy of intravitreal MTX in patients with PIOL

Scientific Title

Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma

Scientific Title:Acronym

Evaluation of therapeutic efficacy of intravitreal MTX in patients with PIOL

Region

Japan


Condition

Condition

primary intraocular lymphoma

Classification by specialty

Ophthalmology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate clinical safety of intravitreal methotrexate in patients with primary intraocular lymphoma.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Systemic and ophthalmological adverse effects and frequency

Key secondary outcomes

1. frequency of intraocular recurrences
2. recurrence-free survival
3. response rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive 0.1ml of MTX (diluted to a concentration of 400ug/0.1ml using saline) by intravitreal injection.
MTX is administrated twice a week for 4 weeks, after that once a week for 4 weeks, and injected at every 4weeks x 12 times.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

patients with primary intraocular lymphoma

Key exclusion criteria

1. performance status 4
2. patients who participated in other clinical trials within three months
3. patients with severe allergy to MTX
4. patients who desire for childbearing
5. patients with severe dementia or psychiatric disorder
6. Patients suggested as ineligible by their attending physician

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kazuhisa
Middle name
Last name Sugiyama

Organization

Kanazawa University Hospital

Division name

Department of opthalmology and visual science

Zip code

9208641

Address

13-1, Takara machi, Kanazawa, Ishikawa, JAPAN

TEL

076-265-2403

Email

yuko-t@med.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Takemoto

Organization

Kanazawa University Hospital

Division name

Department of opthalmology and visual science

Zip code

9208641

Address

13-1, Takara machi, Kanazawa, Ishikawa, JAPAN

TEL

076-265-2403

Homepage URL


Email

yuko-t@med.kanazawa-u.ac.jp


Sponsor or person

Institute

Kanazawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanazawa University Hospital

Address

13-1, Takara-machi, Kanazawa, Ishikawa

Tel

076-265-2049

Email

crc.irb-knz@esct.jp


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

2018 Year 04 Month 10 Day


Related information

URL releasing protocol

stop the trial

Publication of results

Unpublished


Result

URL related to results and publications

stop the trial

Number of participants that the trial has enrolled

0

Results

stop the trial

Results date posted

2021 Year 04 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

stop the trial

Participant flow

stop the trial

Adverse events

stop the trial

Outcome measures

stop the trial

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 03 Month 28 Day

Date of IRB

2018 Year 02 Month 28 Day

Anticipated trial start date

2018 Year 03 Month 28 Day

Last follow-up date

2019 Year 03 Month 27 Day

Date of closure to data entry

2019 Year 03 Month 27 Day

Date trial data considered complete

2019 Year 03 Month 27 Day

Date analysis concluded

2019 Year 03 Month 27 Day


Other

Other related information



Management information

Registered date

2018 Year 04 Month 05 Day

Last modified on

2022 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036332


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name