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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

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

biweekly-CHOP with G-CSF and intrathecal prophylaxis

About this trial

This is an interventional treatment trial for Adult T-cell Leukemia focused on measuring ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nagasaki University Graduate School of Biomedical Science

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Toxicity

CR rate

Progression free survival

Full Information

NCT ID

NCT00145002

First Posted

September 1, 2005

Last Updated

September 20, 2016

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

1. Study Identification

Unique Protocol Identification Number

NCT00145002

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

August 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult T-cell Leukemia, Lymphoma

Keywords

ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

biweekly-CHOP with G-CSF and intrathecal prophylaxis

Primary Outcome Measure Information:

Title

Overall survival

Secondary Outcome Measure Information:

Title

Toxicity

Title

CR rate

Title

Progression free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masao Tomonaga, MD, PhD

Organizational Affiliation

Nagasaki University Graduate School of Biomedical Science

Official's Role

Study Chair

Facility Information:

Facility Name

Nagasaki University Graduate School of Biomedical Science

City

Nagasaki

ZIP/Postal Code

852-8523

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://www.jcog.jp/

Description

Related Info

Adult T-cell Leukemia, Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial