UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020513 |
|---|---|
| Receipt number | R000023680 |
| Scientific Title | MR-CHOP therapy (high dose MTX with R-CHOP) for primary CNS lymphoma. |
| Date of disclosure of the study information | 2016/01/09 |
| Last modified on | 2019/07/13 12:10:19 |
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Basic information
Public title
MR-CHOP therapy (high dose MTX with R-CHOP) for primary CNS lymphoma.
Acronym
MR-CHOP for PCNSL
Scientific Title
MR-CHOP therapy (high dose MTX with R-CHOP) for primary CNS lymphoma.
Scientific Title:Acronym
MR-CHOP for PCNSL
Region
| Japan |
Condition
Condition
primary central nervous system lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
confirmation of efficacy and safety of MR-CHOP treatment for primary CNS lymphoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
CR rate at 6 month after starting treatment
Key secondary outcomes
overall survival, adverse events
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
chemotherapy: MR-CHOP; MTX 2g/m2(day1), Rituximab 375mg/m2(day1), Cyclophosphamide 750mg/m2(day3), Doxorubicin 50mg/m2(day3), Vincristine 1.4mg/m2(day3), prednisolone 100mg(day1-5).
6 courses of MR-CHOP therapy followed by autologous PBSCT with high dose chemotherapy if possible.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Primary CNS lymphoma; pathological confirmation of DLBCL or CD20 positive B malignant cells in cerebrospinal fluid.
2, adult as over 20 y/o
3, written informed consent
Key exclusion criteria
1, extra CNS lesions
2, severe infectious disease
3, history of chemotherapy for lymphoma
4, HIV+, HTLV1+, HBs-Ag+
5, judgement as inappropriate to inclusion to this study by physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Department of Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
TEL
076-218-8158
yasum@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Department of hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
TEL
076-218-8158
Homepage URL
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of hematology and Immunology, Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of hematology and Immunology, Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokuriku CNS lymphoma Research Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023680
