UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000929
Receipt number R000001100
Scientific Title Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Date of disclosure of the study information 2007/12/04
Last modified on 2014/12/26 10:44:02

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Basic information

Public title

Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

Acronym

Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

Scientific Title

Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

Scientific Title:Acronym

Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

Region

Japan


Condition

Condition

CD20 positive diffuse large B cell lmyphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this trial is to investigate clinical benefit of raising a serum concentration of rituximab in R-CHOP for CD20 positive diffuse large B cell lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

phaseII : complete response rate
phaseIII : progression free survival

Key secondary outcomes

phaseII : progression free survival, overall survival, adverse events, seriouse adverse events
phaseIII : overall survival, adverse events, seriouse adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A:R-CHOP

Interventions/Control_2

B:RW+CHOP(weekly rituximab plus CHOP)

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)CD20 positive diffuse large B-cell lymphoma (WHO classification), excluding histological transformation form marginal zone B cell lymphoma or follicular lymphoma and immunodeficiency associated lymphoproliferative disorders.
(2) lymphoma with CD20 positive by immunohistochemistry or flow cytometry
(3)clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry.
(4)stage I disease without bulky mass inappropriate for chemo-radiotherapy
(5)lymphoma cells in peripheral blood: no more than 10000/mm3
(6)Performance Status: 0-2
(7)no CNS invasion
(8)having measurable lesion
(9)no prior chemotherapy, radiotherapy and anti-body therapy
(10)WBC: more than 3000/mm3
(11)neutrophil: more than 1000/mm3
(12)platlets: more than 10x104/mm3
(13)AST: no more than 150 U/L
(14)ALT: male: no more than 210 U/L
female: no more than 115 U/L
(15)T-bil: no more than 2.0mg/dl
(16)creatinine: no more than 2.0mg/dl
(17)normal ECG
(18)ejection fraction: more than 50%
(19)PaO2: more than 65mmHg(room air)
(20)written informed consent

Key exclusion criteria

(1)anamnesis of graucoma
(2)diabetes mellitus treating insulin or uncontrolled
(3)uncontrollable hypertension
(4)coronary artery necessary, cardiomyopathy and heart failure necessary treatment, arrhythmia treating antiarrhyshmic
(5)HBs-Ag positive
(6)HCV positive
(7)HIV positive
(8)interstitial pneumonia, plumonary fiblosis
(9)severe infection
(10)synchronous or metachronous malignancy
(11)pregnant/lactating woman
(12)psychosis
(13)given systemic steroid

Target sample size

422


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohiro Kinoshita

Organization

Aichi Cancer Center Hospital

Division name

Department of Hematology and Cell Therapy

Zip code


Address

1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan

TEL

052-762-6111

Email

kinosita@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Ohmachi

Organization

JCOG0601 Coordinating Office

Division name

Tokai University, Division of Hematology Oncology

Zip code


Address

143 shimokasuya, Isehara, Kanagawa, 259-1193, JAPAN

TEL

0463-93-1121

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

国立病院機構北海道がんセンター(北海道)
札幌北楡病院(北海道)
東北大学病院(宮城県)
秋田大学医学部(秋田県)
太田西ノ内病院(福島県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
がん・感染症センター都立駒込病院(東京都)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学第三病院(東京都)
がん研究会有明病院(東京都)
NTT東日本関東病院(東京都)
東海大学医学部(神奈川県)
金沢医科大学(石川県)
福井大学医学部附属病院(福井県)
浜松医科大学(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋大学医学部(愛知県)
名古屋市立大学病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知医科大学附属病院(愛知県)
豊田厚生病院(愛知県)
三重大学医学部(三重県)
滋賀県立成人病センター(滋賀県)
京都府立医科大学(京都府)
兵庫県立がんセンター(兵庫県)
岡山医療センター(岡山県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
愛媛大学医学部附属病院(愛媛県)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
国立病院機構九州医療センター(福岡県)
産業医科大学(福岡県)
佐賀大学医学部(佐賀県)
国立病院機構長崎医療センター(長崎県)
佐世保市立総合病院(長崎県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
国立病院機構熊本医療センター(熊本県)
大分県立病院(大分県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
今村病院分院(鹿児島県)
琉球大学医学部附属病院(沖縄県)


Other administrative information

Date of disclosure of the study information

2007 Year 12 Month 04 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

No longer recruiting

Date of protocol fixation

2007 Year 10 Month 18 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 04 Day

Last follow-up date

2017 Year 12 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 12 Month 04 Day

Last modified on

2014 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001100


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name