UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012957
Receipt number R000015137
Scientific Title Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma
Date of disclosure of the study information 2014/01/25
Last modified on 2014/01/25 09:52:46

* 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

Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma

Acronym

CLOBRZ study

Scientific Title

Short courses of chemotherapy followed by 90Y-Ibritumomab tiuxetan for relapsed low grade B cell lymphoma

Scientific Title:Acronym

CLOBRZ study

Region

Japan


Condition

Condition

Relapsed low grade B cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of 2 or 3 courses of chemotherapy followed by 90Y-Iburitumomab tiuxetan for relapsed low grade lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

CR rate

Key secondary outcomes

Completion rate, PFS, TTNT(Time to next treatment)


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

2~3 courses of chemotherapy followed by Y90-Ibritumomab tiuxetan

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Relapsed low grade lymphoma patients who require treatment
Measurable lymphoma lesion that is more than 2cm
PS 0~2

Key exclusion criteria

Uncontrollable severe complications
Neutrophils <1200/ul, Platelets <100000/ul

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Fukuda

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code


Address

1-5-45 Yushima, Bunkyoku, Tokyo

TEL

81-3-5803-5211

Email

fuku.hema@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Fukuda

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code


Address

1-5-45 Yushima, Bunkyoku, Tokyo

TEL

81-3-5803-5211

Homepage URL


Email

fuku.hema@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 25 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

Open public recruiting

Date of protocol fixation

2013 Year 12 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 20 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 01 Month 25 Day

Last modified on

2014 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name