# Brentuximab vedotin phase 2 in relapsed systemic anaplastic large cell lymphoma (SG035-0004)

Source: https://onco.cc/trials/brentuximab-salcl-phase-2/  
OnCo record `brentuximab-salcl-phase-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An antibody-drug conjugate aimed at CD30 made the lymphoma shrink in 86 per cent of people with relapsed anaplastic large cell lymphoma, and disappear on scans in more than half.

## Summary

Systemic anaplastic large cell lymphoma uniformly expresses CD30. Brentuximab vedotin is an antibody against CD30 joined to monomethyl auristatin E, a drug that disrupts microtubules. This multicentre phase 2 study gave it at 1.8 mg/kg intravenously every three weeks, as an outpatient infusion, to 58 patients with systemic ALCL that had come back after at least one treatment; the primary endpoint was objective response by independent central review.

Fifty patients (86 per cent) responded and 33 (57 per cent) had a complete remission. The median durations of response and of complete remission were 12.6 and 13.2 months. Grade 3 or 4 adverse events in at least 10 per cent were neutropenia (21 per cent), thrombocytopenia (14 per cent) and peripheral sensory neuropathy (12 per cent). The five-year report (Blood 2017) found no progressions beyond 40 months and eight patients, 14 per cent of those enrolled, in sustained remission with neither a transplant nor any further treatment. The drug was approved in the United States in 2011 for relapsed systemic ALCL, and ECHELON-2 later moved it to first line.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-11-03
- Also known as: SG035-0004; Pro 2012
- Tags: lymphoma-evidence-entities
- Registry id: NCT00866047
- Phase: 2
- Setting: Relapsed or refractory systemic anaplastic large cell lymphoma after at least one prior therapy: brentuximab vedotin 1.8 mg/kg every three weeks
- Sponsor: Seagen Inc.
- Enrolled: 58
- Result: Objective response 86 per cent and complete remission 57 per cent in 58 patients with relapsed systemic ALCL.
- Outcomes: Objective response rate (independent central review): Brentuximab vedotin 86%; Complete remission rate: Brentuximab vedotin 57%
- Replication: Not repeated in relapsed disease; the randomised ECHELON-2 then tested the drug in first line and lengthened survival.

## Sources

- ClinicalTrials.gov NCT00866047: https://clinicaltrials.gov/study/NCT00866047
- Journal of Clinical Oncology 2012: https://doi.org/10.1200/JCO.2011.38.0402
- Blood 2017: five-year results: https://doi.org/10.1182/blood-2017-05-780049

## Connected records

- cancers: [ALK-negative anaplastic large cell lymphoma](https://onco.cc/cancers/alk-negative-anaplastic-large-cell-lymphoma/), [ALK-positive anaplastic large cell lymphoma](https://onco.cc/cancers/alk-positive-anaplastic-large-cell-lymphoma/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- fronts: [Antibody-Drug Conjugates](https://onco.cc/fronts/adcs/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [CD30](https://onco.cc/targets/cd30/)
- drugs: [Brentuximab vedotin](https://onco.cc/drugs/brentuximab-vedotin/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Complete response](https://onco.cc/terms/complete-response/), [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- trials: [ECHELON-2](https://onco.cc/trials/echelon-2/)
- key papers: [Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study](https://onco.cc/key-papers/paper-brentuximab-relapsed-salcl-phase-2-jco-2012/), [Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma](https://onco.cc/key-papers/paper-brentuximab-relapsed-salcl-five-year-blood-2017/)

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