Clinical trial · Interventional
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-cell Leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
NCT00145002CI-TRIAL-00023998completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult T-cell Leukemia | Adult T-Cell Leukemia/Lymphoma | PROBABILISTIC | 0.70 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biweekly-CHOP with G-CSF and intrathecal prophylaxis | Drug | — | UNRESOLVED |
| VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (3)
- measure
- Toxicity
- measure
- CR rate
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.