UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014072 |
|---|---|
| Receipt number | R000016337 |
| Scientific Title | A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with CD20 positive B-cell lymphoma |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/03/26 07:34:42 |
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Basic information
Public title
A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with CD20 positive B-cell lymphoma
Acronym
A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with B-cell lymphoma
Scientific Title
A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with CD20 positive B-cell lymphoma
Scientific Title:Acronym
A phase I/II clinical study of expanded autologous NK cell combined with rituximab-based chemotherapy in patients with B-cell lymphoma
Region
| Japan |
Condition
Condition
relapsed/refractory CD20 positive B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of expanded autologous NK cell combined with rituximab-based chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety:
Evaluation by NCI-CTCAE ver 4.0
Key secondary outcomes
Efficacy:
Clinical response rate
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 | Other |
Interventions/Control_1
Expanded autologous NK cell is administered intravenously on the day after completion of rituximab-based chemotherapy.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed CD20 positive B-cell lymphoma
2. Patients who are refractory to standard chemotherapy
3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0-2
4. Expected survival period is more than 3 months
5. Obtaining written informed consent
Key exclusion criteria
1. Patients with active infections
2. Patients with severe complications
3. Pregnant or lactating women
4. Patients with history of severe allergy
5. Patients medicated with the immunosuppressive agents
6. Inappropriate patients for this study judged by the physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tanaka |
Organization
Tokyo Women's Medical University
Division name
Department of Hematology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
jutanaka@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norina Tanaka |
Organization
Tokyo Women's Medical University
Division name
Department of Hematology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
tanaka.norina@twmu.ac.jp
Sponsor or person
Institute
Department of Hematology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tella, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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 | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016337
