Adult T-cell LeukemiaPhase 3NCT00145002
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
A Phase 3 study testing VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis and biweekly-CHOP with G-CSF and intrathecal prophylaxis in people with Adult T-cell Leukemia and Lymphoma, run by Japan Clinical Oncology Group at 1 site in Japan.
Trial summary
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Adult T-cell Leukemia, Lymphoma
- What is being tested?
- VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis and biweekly-CHOP with G-CSF and intrathecal prophylaxis
- How many people
- 130 participants
- Where
- 1 siteJapan
- Study dates
- Aug 1998to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
- Aged 15-69 years
- No prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
- Preserved organ (bone marrow, liver, kidney, heart and lung) functions
- All patients were required to provide written informed consent
Who cannot join
- Diabetes mellitus necessitating treatment with insulin
- Active systemic infection
- Cardiac disorders expected to become worse as a result of the DOX-containing regimen
- Acute hepatitis, chronic hepatitis or liver cirrhosis
- Positive for HBs Ag or anti-HCV Ab
- Active concurrent malignancy
Show all 9Show fewer
- Other serious medical or psychiatric conditions
- Pregnancy or breast feeding
- Central nervous system involvement by ATL cells
Trial locations and contacts
1 site in 1 country.
Japan1 site
Nagasaki University Graduate School of Biomedical Science
Nagasaki, Nagasaki, 852-8523
About this study
Official 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.
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Read the detailed description
Nothing to describe.
- Conditions
- Adult T-cell Leukemia, Lymphoma
- Being tested
- VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis, biweekly-CHOP with G-CSF and intrathecal prophylaxis
- Keywords
- ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP
- Medical subject headings
- Leukemia-Lymphoma, Adult T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCAP-AMP-VECP with G-CSF and intrathecal prophylaxisDrug
biweekly-CHOP with G-CSF and intrathecal prophylaxisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (3)
Toxicity
CR rate
Progression free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startAug 1998
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult T-cell LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Masao Tomonaga, MD, PhD, Study chair, Nagasaki University Graduate School of Biomedical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145002
- Sponsor's protocol ID
- JCOG9801
- Other IDs
- C000000066
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00145002
- Acronym / sponsor ID
- JCOG9801
- Conditions
- Adult T-cell Leukemia, Lymphoma
- Keywords
- ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Aug 1998
- Study completion
- Dec 2004
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Detailed description
Nothing to describe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
- Aged 15-69 years
- No prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
Key exclusion criteria (9 listed)
- Diabetes mellitus necessitating treatment with insulin
- Active systemic infection
- Cardiac disorders expected to become worse as a result of the DOX-containing regimen
- Acute hepatitis, chronic hepatitis or liver cirrhosis
- Positive for HBs Ag or anti-HCV Ab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis | Drug | – |
| biweekly-CHOP with G-CSF and intrathecal prophylaxis | Drug | – |
Primary outcome
Overall survival
3 secondary outcomes
Toxicity
CR rate
Progression free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masao Tomonaga, MD, PhD study chair
Nagasaki University Graduate School of Biomedical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis and biweekly-CHOP with G-CSF and intrathecal prophylaxis in people with Adult T-cell Leukemia and Lymphoma, run by Japan Clinical Oncology Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.