UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007950 |
|---|---|
| Receipt number | R000009365 |
| Scientific Title | Efficacy of ibritumomab tiuxetan (Zevalin) following remission induction therapy for relapse of follicular lymphoma |
| Date of disclosure of the study information | 2012/05/15 |
| Last modified on | 2016/05/14 09:29:29 |
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Basic information
Public title
Efficacy of ibritumomab tiuxetan (Zevalin) following remission induction therapy for relapse of follicular lymphoma
Acronym
Ibritumomab tiuxetan (Zevalin) for relapse of follicular lymphoma
Scientific Title
Efficacy of ibritumomab tiuxetan (Zevalin) following remission induction therapy for relapse of follicular lymphoma
Scientific Title:Acronym
Ibritumomab tiuxetan (Zevalin) for relapse of follicular lymphoma
Region
| Japan |
Condition
Condition
Follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and safety of consolidation with ibritumomab tiuxetan (Zevalin) following induction therapy, for patients with relapsed follicular lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
2-year progression-free survival rate
Key secondary outcomes
Progression-free survival
Overall survival
Complete remission rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with relapsed follicular lymphoma of clinical stage 3 or 4.
2) Lymphoma cells were CD20-positive by immunohistochemistry or flow cytometry.
3) Induction treatment for relapsed follicular lymphoma has been completed, within 3 months of registration.
4) Partial or complete remission has been achieved by induction therapy for relapsed follicular lymphoma.
5) Performance status (ECOG) were either 0 or 1.
6) Written informed consent was obtained.
Key exclusion criteria
1) Patients with uncontrollable infection.
2) Intolerable allergy for rituximab or drugs derived from murine proteins.
3) Previous history of allogeneic stem cell transplant.
4) Pregnant (or possibly pregnant) patient
5) Patients receiving anti-coagulants or anti-thrombotic agents.
6) Patients with hemorrhagic symptoms.
7) Patients receiving external radiation for more than 25% of total bone marrow.
8) Patients planning to undergo rituximab maintenance therapy.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiko Nakamura |
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 |
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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
Entry completed
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
| 2012 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Not applicable
Management information
Registered date
| 2012 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009365
