# JCOG9801

Source: https://onco.cc/trials/jcog9801/  
OnCo record `jcog9801` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The only randomised trial ever run exclusively in the virus-driven T-cell leukaemia found an intensive Japanese regimen better than standard chemotherapy, at the cost of much more severe low blood counts.

## Summary

Adult T-cell leukaemia/lymphoma is caused by human T-lymphotropic virus type 1, a virus endemic in southwestern Japan, where Hinuma's seroepidemiology found antibodies in 26 per cent of healthy adults, and in a small number of other regions. JCOG9801 is the only randomised controlled trial conducted exclusively in the disease. 118 previously untreated patients with aggressive disease were assigned to six courses of VCAP-AMP-VECP, a Japanese three-part regimen, every four weeks, or to eight courses of CHOP every two weeks. Both arms used granulocyte colony-stimulating factor support and intrathecal prophylaxis.

The complete response rate was higher with VCAP-AMP-VECP, 40 against 25 per cent (p = 0.020). One-year progression-free survival was 28 against 16 per cent (p = 0.100, two-sided p = 0.200) and three-year overall survival 24 against 13 per cent (p = 0.085, two-sided p = 0.169), so the time-to-event endpoints did not reach significance. Grade 4 neutropenia occurred in 98 against 83 per cent, grade 4 thrombocytopenia in 74 against 17 per cent and grade 3 or 4 infection in 32 against 15 per cent, with three toxic deaths in the intensive arm.

The trial is quoted as establishing VCAP-AMP-VECP as the Japanese standard, and the survival numbers are the honest reason the field has kept looking: three-year overall survival of 24 per cent is what the best available chemotherapy achieved. Allogeneic transplantation, mogamulizumab and interferon with zidovudine in the leukaemic subtypes are the routes that followed. The disease has no cancer record of its own in OnCo yet; it is attached here to peripheral T-cell lymphoma.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-10-01
- Also known as: JCOG9801; VCAP-AMP-VECP versus biweekly CHOP in adult T-cell leukaemia/lymphoma; LSG15
- Tags: lymphoma-evidence
- Registry id: NCT00145002
- Phase: 3
- Setting: Untreated aggressive adult T-cell leukaemia/lymphoma: six courses of VCAP-AMP-VECP every four weeks against eight courses of CHOP every two weeks
- Sponsor: Japan Clinical Oncology Group
- Enrolled: 118
- Result: Complete response 40 against 25 per cent (p = 0.020) and three-year overall survival 24 against 13 per cent, with grade 4 thrombocytopenia in 74 against 17 per cent.
- Outcomes: Complete response rate: VCAP-AMP-VECP 40% vs Biweekly CHOP 25%; Overall survival at 3 years: VCAP-AMP-VECP 24% vs Biweekly CHOP 13%
- Replication: Never repeated; no second randomised trial has been run exclusively in this disease.

## Sources

- ClinicalTrials.gov NCT00145002: https://clinicaltrials.gov/study/NCT00145002
- Journal of Clinical Oncology 2007: https://doi.org/10.1200/JCO.2007.11.9958

## Connected records

- cancers: [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Etoposide](https://onco.cc/drugs/etoposide/), [Prednisone](https://onco.cc/drugs/prednisone/), [Vincristine](https://onco.cc/drugs/vincristine/)
- terms: [CNS prophylaxis in aggressive B-cell lymphoma, and the evidence against it](https://onco.cc/terms/lymphoma-tx-cns-prophylaxis/), [Complete response](https://onco.cc/terms/complete-response/), [Intrathecal therapy (lumbar puncture, Ommaya reservoir)](https://onco.cc/terms/intrathecal-therapy/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)
- key papers: [Adult T-cell leukemia: antigen in an ATL cell line and detection of antibodies to the antigen in human sera](https://onco.cc/key-papers/paper-hinuma-adult-t-cell-leukaemia-antigen-pnas-1981/), [Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma](https://onco.cc/key-papers/paper-poiesz-htlv-retrovirus-cutaneous-t-cell-lymphoma-pnas-1980/), [VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801](https://onco.cc/key-papers/paper-jcog9801-vcap-amp-vecp-adult-t-cell-leukaemia-jco-2007/)
- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- ideas: [Randomised evidence for the T-cell lymphomas, including the ones that are not in Europe or North America](https://onco.cc/ideas/lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas/)
- trials: [ECHELON-2](https://onco.cc/trials/echelon-2/)

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