UMIN-CTR Clinical Trial

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
Email	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
Email	yasum@kanazawa-med.ac.jp

Sponsor
Institute	Department of hematology and Immunology, Kanazawa Medical University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023680