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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name