UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of ibritumomab tiuxetan (Zevalin) following remission induction therapy for relapse of follicular lymphoma
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Fumihiko Nakamura
Organization	The University of Tokyo Hospital
Division name	Department of Hematology and Oncology
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	Fumihiko Nakamura
Organization	The University of Tokyo Hospital
Division name	Department of Hematology and Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Entry completed
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009365