UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012730 |
|---|---|
| Receipt number | 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 09:34:02 |
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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
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
fnakamur-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014871
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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