A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL) | NCT00145002

Studies
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)

NCT00145002

Sponsor

Japan Clinical Oncology Group

Status

Completed

Last Update Posted

Sep 22, 2016Estimated

Enrollment

130

Phase

Phase 3

Conditions

Adult T-cell Leukemia
Lymphoma

Interventions

VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis
biweekly-CHOP with G-CSF and intrathecal prophylaxis

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
C000000066

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1998

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Measure	Description	Time Frame
Overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Other serious medical or psychiatric conditions
Pregnancy or breast feeding
Central nervous system involvement by ATL cells

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masao Tomonaga, MD, PhD	Nagasaki University Graduate School of Biomedical Science	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagasaki University Graduate School of Biomedical Science		Nagasaki	Nagasaki	852-8523	Japan

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D015459	Leukemia-Lymphoma, Adult T-Cell
D008223	Lymphoma

Ancestor Terms

ID	Term
D015458	Leukemia, T-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis	Drug
biweekly-CHOP with G-CSF and intrathecal prophylaxis	Drug