UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007821 |
|---|---|
| Receipt number | R000002307 |
| Scientific Title | A Prospective Study of Diagnosis and Therapeutics in Intraocular Malignant Lymphoma |
| Date of disclosure of the study information | 2012/04/23 |
| Last modified on | 2021/05/14 11:02:58 |
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Basic information
Public title
A Prospective Study of Diagnosis and Therapeutics in Intraocular Malignant Lymphoma
Acronym
A Prospective Study of Diagnosis and Therapeutics in Intraocular Malignant Lymphoma
Scientific Title
A Prospective Study of Diagnosis and Therapeutics in Intraocular Malignant Lymphoma
Scientific Title:Acronym
A Prospective Study of Diagnosis and Therapeutics in Intraocular Malignant Lymphoma
Region
| Japan |
Condition
Condition
Uveitis suspected as Intraocular Malignant Lymphoma
Classification by specialty
| Hematology and clinical oncology | Ophthalmology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) We perform vitrectomy to obtain the vitreous samples of uveitis suspected as intraocular malignant lymphoma (IOL), and determine the diagnosis of IOL according to the diagnostic criteria we determined. By following-up the cases, we evaluate the accuracy of the diagnostic criteria.
Basic objectives2
Others
Basic objectives -Others
2) We perform the treatments (intraocular methotrexate injections, systemic chemotherapy and low-dose whole brain radiation therapy (23.4Gy)) according to the treatment protocol we determined. By following-up the cases, we evaluate the efficacy of the protocol prospectively.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic efficacy (sensitivity) of the diagnostic criteria
Local recurrence ratio, systemic recurrence ratio, overall survival, progression-free survival
Key secondary outcomes
Classification of the papanicolaou staing of the vitrecous specimens, concentration of IL10/IL-6 of vitreous samples, IgH monoclonarity, final visual acuity, site of systemic dissemination, term during therapy and recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
1)Primary Intraocular lymphoma (IOL) only with primary systemic malignant lymphoma (ML): intravitreal injection of 0.4mg of MTX(totally 10times, once a week for 2 months and once a month for 2 months)+ R-MPV therapy (1st day:rituximab 375mg/m2, 2nd day: oncovin 1.4mg/m2 (maximum 2mg)+MTX 3.5g/m2, 1-7day: procarbazine 100mg/m2 (odd number course only)) 5-7 course + whole-brain radiotherapy (totally 23.4 Gy) + High dose Ara C therapy 2 course (High dose cytarabine 3 g/m2/day (maximum daily dose 6g) for 2 days).
Systemic chemotherapy will be performed repeatedly 5 courses, one course in every 2 or 3 weeks.
Interventions/Control_2
2)Primary Intraocular lymphoma (IOL) with primary systemic malignant lymphoma (ML): intravitreal injection of 0.4mg of MTX(totally 10times, once a week for 2 months and once a month for 2 months)+ R-MPV therapy (1st day:rituximab 375mg/m2, 2nd day: oncovin 1.4mg/m2 (maximum 2mg)+MTX 3.5g/m2, 1-7day: procarbazine 100mg/m2 (odd number course only)) 5-7 course + whole-brain radiotherapy (totally 23.4-45 Gy) + High dose Ara C therapy 2 course (High dose cytarabine 3 g/m2/day (maximum daily dose 6g) for 2 days).
Systemic chemotherapy will be performed repeatedly 5 courses, one course in every 2 or 3 weeks.
Interventions/Control_3
In cases of recurrence of intraocular lymphoma without systemic lymphoma:
intravitreal injection of 0.4mg of MTX (totally 10 times, once a week for 2 months and once a month for 2 months) only.
Interventions/Control_4
In cases of intraocular lymphoma with systemic lymphoma or with the previous history of systemic lymphoma:
Local injection of MTX (totally 10 times, once a week for 2 months and once a month for 2 months, systemic chemotherapy, irradiation (Stem cell transplantation should be considered. Contents of chemotherapy are not specified.)
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
Age: 20-75 years old
Selection criteria
1) cases with uveal inflammation, which is suspected as intraocular malignant lymphoma, and vitreous biopsy was done for diagnostic purposes.
2) Diagnostic criteria for intraocular lymphoma is as follows.
(a) the vitreous fluid cytology
(class 5) 3 points
(Class 4) 2 points
(Class 3) 1 point
(b) IL-10/IL-6 (>1) or IL-10> 50pg/ml) 2 points
(c) IgH monoclonality 2 points
(d) FACS (distribution of kappa and lambda) 2 points
(e) funduscopic findings that are characteristic of intraocular lymphoma (the aurora-like vitreous opacity or patchy cell infiltration of the retina (often with serous retinal detachment)). 1 point
(f) the pathological diagnosis of malignant lymphoma of the eye or other organs before. 1 point
If the sum of these 6 items is more than 4 points, we diagnose intraocular lymphoma.
3) adaptation of the treatment protocol: Ccr> 50
Key exclusion criteria
Except for performance status 4
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | RIE |
| Middle name | |
| Last name | TANAKA |
Organization
University of Tokyo Hospital
Division name
Ophthalmology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
03-3815-5411
rtanaka-ymn@umin.ac.jp
Public contact
Name of contact person
| 1st name | RIE |
| Middle name | |
| Last name | TANAKA |
Organization
University of Tokyo Hospital
Division name
Ophthalmology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
03-3815-5411
Homepage URL
rtanaka-ymn@umin.ac.jp
Sponsor or person
Institute
Deportment of Ophthalmology, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Deportment of Ophthalmology, University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Cancer institute hospital of Japanese Foundation For Cancer Research
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Graduate School of Medicine and Faculty of Medicine at The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
東京大学付属病院眼科（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.14848
Number of participants that the trial has enrolled
17
Results
17 patients initiated and 16 completed the treatment. CNS relapse occurred in 2 and intraocular relapse in 3. 4-year PFS was 74.9% and 4-year OS was 86.3%. Of 11 patients without CNS involvement, 1 had CNS relapse and 3 intraocular relapse, and 4-year PFS was 72.7% and 4-year OS was 88.9%. No patients developed dementia/leukoencephalopathy. The combination of intravitreal chemotherapy, systemic chemotherapy and rdWBRT for B-cell PIOL showed a potential to reduce CNS relapse and improved 4-year PFS and OS.
Results date posted
| 2020 | Year | 05 | Month | 09 | Day |
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Kaburaki T, Taoka K, Matsuda J, Yamashita H, Matsuda I, Tsuji H, Tanaka R, Nakazaki K, Nakamura F, Kamiya K, Kurokawa M, Ohtomo K, Aihara M. Combined intravitreal methotrexate and immunochemotherapy followed by reduced-dose whole-brain radiotherapy for newly diagnosed B-cell primary intraocular lymphoma. Br J Haematol. 2017 Oct;179(2):246-255. doi: 10.1111/bjh.14848.
Management information
Registered date
| 2012 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002307
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