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

J

Japan Clinical Oncology Group

Status and phase

Completed
Phase 3

Conditions

Lymphoma
Adult T-cell Leukemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00145002
C000000066
JCOG9801

Details and patient eligibility

About

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

Full description

Nothing to describe.

Sex

All

Ages

15 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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