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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012730
Receipt No. R000014871
Scientific Title Prospective, single-center, and exploratory study of temozolomide and rituximab for relapsed/refractory central nervous system lymphoma.
Date of disclosure of the study information 2014/01/06
Last modified on 2017/01/09

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Basic information
Public title Prospective, single-center, and exploratory study of temozolomide and rituximab for relapsed/refractory central nervous system lymphoma.
Acronym Temozolomide and rituximab for relapsed/refractory central nervous system lymphoma.
Scientific Title Prospective, single-center, and exploratory study of temozolomide and rituximab for relapsed/refractory central nervous system lymphoma.
Scientific Title:Acronym Temozolomide and rituximab for relapsed/refractory central nervous system lymphoma.
Region
Japan

Condition
Condition Relapsed/refractory central nervous system lymphoma
Classification by specialty
Hematology and clinical oncology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to assess efficacy and safety of temozolomide for relapsed/refractory central nervous system lymphoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall response rate and complete response rate.
Key secondary outcomes Overall survival, and progression-free survival.

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 Treatment with temozolomide and rituximab
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. Patients with relapsed/refractory central nervous system lymphoma carrying a measurable lesion on brain MRI.
2. High-dose methotrexate and high-dose cytarabine are ineffective or intolerable.
3. Absolute neutrophil count >= 1*10^9 /L.
4. Platelet count >= 50*10^9 /L.
5. Tumor cells express CD20.
Key exclusion criteria 1. Presence of uncontrollable infection.
2. Positive for serum anti-HIV antibody.
3. Positive for serum anti-HBV antigen or elevated serum HBV-DNA level.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiko Nakamura, MD, PhD
Organization The University of Tokyo Hospital
Division name Department of Hematology and Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8741
Email fnakamur-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiko Nakamura, MD, PhD
Organization The University of Tokyo Hospital
Division name Department of Hematology and Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8741
Homepage URL
Email fnakamur-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2014 Year 01 Month 06 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 30 Day
Last modified on
2017 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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