# Randomised evidence for the T-cell lymphomas, including the ones that are not in Europe or North America

Source: https://onco.cc/ideas/lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas/  
OnCo record `lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adult T-cell leukaemia has had one randomised trial, in 1998. Most T-cell lymphoma treatment rests on single-arm studies, and the diseases concentrated outside Europe and North America have the least evidence of all.

## Summary

The obstacles are structural rather than scientific: no commercial sponsor for diseases concentrated in middle-income countries, regulatory fragmentation across the regions where the diseases occur, and the fact that a trial in a disease with 500 cases a year in any one country can only work internationally. The precedent is the international coordination that made paediatric leukaemia trials possible, which took decades and worked.

## Fields

- Kind: Idea
- Last checked: 2026-10-01
- Also known as: Randomised trials in peripheral T-cell lymphoma; International trials for NK/T-cell and adult T-cell lymphoma
- Tags: lymphoma-evidence
- Hypothesis: Internationally coordinated randomised trials in the T-cell lymphomas, run where the diseases are concentrated, would change first-line standards that currently rest on single-arm series.
- Rationale: JCOG9801 is the only randomised controlled trial ever run exclusively in adult T-cell leukaemia/lymphoma, with 118 patients, reported in 2007, and its three-year overall survival of 24 per cent in the better arm has not been improved on by a controlled comparison since. SMILE, the regimen that made extranodal NK/T-cell lymphoma treatable, is a 38-patient single-arm phase 2. ECHELON-2 and ALCANZA show that randomised trials in T-cell lymphoma are feasible and change practice when an industry sponsor has a reason to run them. The diseases without a sponsor have no trials.
- Proposed test: A standing international platform trial in peripheral T-cell lymphoma with disease-specific strata for adult T-cell leukaemia/lymphoma and extranodal NK/T-cell lymphoma, hosted in Japan, Korea, China, Brazil and the Caribbean as well as in Europe and North America, with a shared control arm and the statistical borrowing that makes rare-disease strata viable.
- Maturity: speculative
- Actor: policy

## Connected records

- 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/)
- cancers: [Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome)](https://onco.cc/cancers/cutaneous-t-cell-lymphoma/), [Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma)](https://onco.cc/cancers/angioimmunoblastic-t-cell-lymphoma/), [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/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- targets: [CD30](https://onco.cc/targets/cd30/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [Brentuximab vedotin](https://onco.cc/drugs/brentuximab-vedotin/), [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/)
- trials: [ALCANZA](https://onco.cc/trials/alcanza/), [ECHELON-2](https://onco.cc/trials/echelon-2/), [JCOG9801](https://onco.cc/trials/jcog9801/), [SMILE](https://onco.cc/trials/smile-enktl/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [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/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)
- key papers: [ALCANZA: brentuximab vedotin versus physician's choice in CD30-positive cutaneous T-cell lymphoma](https://onco.cc/key-papers/paper-alcanza-brentuximab-vedotin-lancet-2017/), [Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial](https://onco.cc/key-papers/paper-horwitz-lancet/), [Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer (NK)/T-cell lymphoma, nasal type: the NK-Cell Tumor Study Group study](https://onco.cc/key-papers/paper-smile-chemotherapy-nk-t-cell-lymphoma-jco-2011/), [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/)

---
JSON: https://onco.cc/api/v1/entities/lymphoma-ev-randomised-evidence-for-the-t-cell-lymphomas.json