adult T-cell leukemia / lymphoma
Conditions
Interventions
VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis.
biweekly-CHOP with G-CSF and intrathecal prophylaxis.
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
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) functons. 7) All patients were required to provide written informed consent.
Exclusion criteria
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 rrhosis. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, CR rate, Progression free survival | — |
Countries
Japan
Contacts
Public ContactKunihiro Tsukasaki, MD, PhD
JCOG9801 Coordinating Office Department of Hematology, Nagasaki University Graduate School of Biomedical Science
Outcome results
None listed