NCT00145002

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

First QC Date

September 1, 2005

Last Update Submit

September 20, 2016

Conditions

Adult T-cell LeukemiaLymphoma

Keywords

ATLLchemotherapyphase III studyVCAP-AMP-VECPbiweekly-CHOP

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (3)

  • Toxicity

  • CR rate

  • Progression free survival

Interventions

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

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagasaki University Graduate School of Biomedical Science

Nagasaki, Nagasaki, 852-8523, Japan

Location

Related Links

MeSH Terms

Conditions

Leukemia-Lymphoma, Adult T-CellLymphoma

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Masao Tomonaga, MD, PhD

    Nagasaki University Graduate School of Biomedical Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

August 1, 1998

Study Completion

December 1, 2004

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(1)