UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000968 |
|---|---|
| Receipt number | R000001166 |
| Scientific Title | Treatment for CD20-positive central nervus system lymphoma with autologous serum and rituximab into the ventricle |
| Date of disclosure of the study information | 2008/01/15 |
| Last modified on | 2010/06/18 15:43:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Treatment for CD20-positive central nervus system lymphoma with autologous serum and rituximab into the ventricle
Acronym
CNS lymphoma treatment with auto-serum and rituximab into the ventricle
Scientific Title
Treatment for CD20-positive central nervus system lymphoma with autologous serum and rituximab into the ventricle
Scientific Title:Acronym
CNS lymphoma treatment with auto-serum and rituximab into the ventricle
Region
| Japan |
Condition
Condition
CD20-positive primary central nervus system lymphoma, or relapsed CD20-positive non-Hodgkin lymphoma in CNS alone
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of novel immunotherapy for refractory CNS lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Day 1: Intraventricle injection of 10 mg (1 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir.
Day 3: Intraventricle injection of 40 mg (4 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir.
Day 6: Intraventricle injection of 50 mg (5 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir.
Day 7-14: Ovservation. Above day 1 to day 14 is defined as a course.
The therapy can be repeated by two or more courses if the disease is improved or stable.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
With written informed concent, relapsed or primary refractory CD20-positive primary CNS lymphoma, or relapsed non-Hodgkin lymphoma in CNS alone, which was treated with chemotherapy of multiple drugs including high dose methotrexate or high dose AraC, or with autologous hematopoietic cell transplantation (AHCT). The patient must be considered but are not candidate for radiation or other therapies because these therapies are considered to be ineffective or bring serious side effects, or the patient did not consent to these therapies. If the patient has not been treated with AHCT, the modality must be considered but is concluded as not feasible because of the patient's age, comobidities or rejection.
Key exclusion criteria
Poor general status (ECOG Performance status 3 or 4).
Inablity in understanding of the therapy even due to the primary disease.
Lesions outside of central nervas system which are uncontroled or less than three months from shrinking.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Okoshi |
Organization
University of Tsukuba
Division name
Division of Hematology
Zip code
Address
Tennoudai 1-1-1, Tsukuba, Ibaraki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tsukuba
Division name
Division of Hematology
Zip code
Address
TEL
Homepage URL
yokoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
Division of Hematology, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Tsukuba Critical Path Research and Education Integrated Leading Center
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 01 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 06 | Day |
Last modified on
| 2010 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001166
