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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000066
Receipt No. 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

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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
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

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
URL(English) https://upload.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


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