UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000066
Receipt number R000000111
Scientific Title Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Date of disclosure of the study information 2005/08/17
Last modified on 2014/02/21 14:00:00

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Basic information

Public title

Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Acronym

Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Scientific Title

Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Scientific Title:Acronym

Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Region

Japan


Condition

Condition

adult T-cell leukemia / lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Toxicity, CR rate, Progression free survival


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

VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis.

Interventions/Control_2

biweekly-CHOP with G-CSF and intrathecal prophylaxis.

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

15 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1) Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy.
2) Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL.
3) Aged 15-69 years.
4) No prior chemotherapy or radiotherapy.
5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia.
6) Preserved organ (bone marrow, liver, kidney, heart and lung) functons.
7) All patients were required to provide written informed consent.

Key exclusion criteria

1) Diabetes mellitus necessitating treatment with insulin.
2) Active systemic infection.
3) Cardiac disorders expected to become worse as a result of the DOX-containing regimen.
4) Acute hepatitis, chronic hepatitis or liver rrhosis.
5) Positive for HBs Ag or anti-HCV Ab.
6) Active concurrent malignancy.
7) Other serious medical or psychiatric conditions.
8) Pregnancy or breast feeding.
9) Central nervous system involvement by ATL cells.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Tomonaga, MD, PhD

Organization

Nagasaki University Graduate School of Biomedical Science

Division name

Department of Hematology

Zip code


Address

1-12-4 Sakamoto, Nagasaki 852-8523, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kunihiro Tsukasaki, MD, PhD

Organization

JCOG9801 Coordinating Office

Division name

Department of Hematology, Nagasaki University Graduate School of Biomedical Science

Zip code


Address

1-12-4 Sakamoto, Nagasaki 852-8523, Japan

TEL


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

J


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00145002

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/17968021

Number of participants that the trial has enrolled


Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Completed

Date of protocol fixation

1998 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

1998 Year 08 Month 01 Day

Last follow-up date

2004 Year 12 Month 01 Day

Date of closure to data entry

2005 Year 02 Month 01 Day

Date trial data considered complete

2005 Year 02 Month 01 Day

Date analysis concluded

2005 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 17 Day

Last modified on

2014 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name