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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2004-12-31

Brief Summary

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

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Detailed Description

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Nothing to describe.

Conditions

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Adult T-cell Leukemia Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

biweekly-CHOP with G-CSF and intrathecal prophylaxis

Intervention Type DRUG

Eligibility Criteria

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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) functions
7. All patients were required to provide written informed consent

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 cirrhosis
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

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No