UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007282
Receipt number R000008319
Scientific Title The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study
Date of disclosure of the study information 2012/02/13
Last modified on 2014/02/14 08:14:58

* 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

The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

Acronym

The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

Scientific Title

The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

Scientific Title:Acronym

The randomized controlled trial of the R-THP-COP therapy versus R-CHOP therapy for treatment of elderly patients with untreated advanced stage diffuse large B-cell lymphoma, Phase II and III study

Region

Japan


Condition

Condition

diffuse large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of R-THP-COP therapy in comparison to R-CHOP therapy for the treatment of patients aged 60 years or older with advanced stage untreated diffuse large B-cell lymphoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Remission rate

Key secondary outcomes

response rate, survival time, safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

R-THP-COP therapy

Interventions/Control_2

R-CHOP therapy

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who have been aounced as non-Hodgkin lymphoma.
2)Patients with histologically confirmed diffuse large B-Cell lymphomas (WHO classification 2008)
3)Patients with CD20-positive non-Hodgkin lymphoma on immunohistochemistry or flowcytometry.
4)Ann Arbor Stage:II, III, IV
5)Patients must have measurable disease.
6)Patients who were not previously treated.
7)Patients over 60 years.
8)ECOG performance status 0-3
9)Life expectancy greater than 4 months.
10)Patients must have normal marrow and organ function as defined below
10-1) Bone marrow function
Absolute neutrophil count >= 1000/mm3
Platelet count >= 50,000/mm3
Hemoglobin >= 8.0 g/dL
10-2) Liver funciton
AST, ALT <= 2.5 x ULN
ALP <= 2.5 x ULN
Total bilirubin <= 1.5 x ULN
10-3) Renal function
Serum creatinine <= 2.0 x ULN
10-4) Cardiac function
Normal electrocardiogram and cardiac function (without severe heart failure or cardiac arrhythmia)
11)Patients who give a written informed consent.

Key exclusion criteria

1)Patients with HIV or HTLV-1.
2)Patients with uncontrolled intercurrent illness including, but not limited to, malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months , liver cirrhosis, uncontrolled hyperglycemia, renal failure, pulmonary fibrosis, or bleeding tendency.
3)Patients with another active malignancy
4)Patients who are pregnant or lactating, or have an intention to get pregnant
5)Patients with severe mental disease.
6)Patients who have had chemotherapy or radiotherapy prior to entering the study.
7)Patients who are judged inappropriate for the entry into the study by the principle doctor.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Tsurumi

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu

TEL

058-230-6000

Email

htsuru@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Tsurumi

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Yanagido Gifu

TEL

058-230-6000

Homepage URL


Email

htsuru@gifu-u.ac.jp


Sponsor or person

Institute

Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu University Hospital First Department of Internal Medicine

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

岐阜大学医学部附属病院(岐阜県)
木曽川市民病院(愛知県)
岐阜市民病院(岐阜県)
岐阜赤十字病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 13 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

2006 Year 05 Month 30 Day

Date of IRB


Anticipated trial start date

2008 Year 07 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



Management information

Registered date

2012 Year 02 Month 13 Day

Last modified on

2014 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name