# Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study

Source: https://onco.cc/key-papers/paper-brentuximab-relapsed-salcl-phase-2-jco-2012/  
OnCo record `paper-brentuximab-relapsed-salcl-phase-2-jco-2012` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The study in which brentuximab vedotin made relapsed systemic anaplastic large cell lymphoma shrink in 86 per cent of patients and disappear on scans in 57 per cent.

## Summary

A multicentre phase 2 trial of brentuximab vedotin 1.8 mg/kg intravenously every three weeks over 30 minutes, as an outpatient infusion, in patients with systemic anaplastic large cell lymphoma recurring after at least one prior therapy. The primary endpoint was overall objective response by independent central review.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Also known as: Pro 2012; SG035-0004
- Tags: lymphoma-evidence-entities
- Journal: Journal of Clinical Oncology
- Year: 2012
- DOI: 10.1200/JCO.2011.38.0402
- Authors: Pro B, Advani R, Brice P, et al.
- Findings: Of 58 patients, 50 (86 per cent) had an objective response: 33 (57 per cent) complete and 17 (29 per cent) partial.; The median durations of overall 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).
- What it means: The evidence behind the statement on both ALCL pages that brentuximab vedotin is highly active at relapse, and the step that led to ECHELON-2 and first-line use.
- Caveats: Single arm, 58 patients.; ALK-positive and ALK-negative disease were both included; the response rates by ALK status are in the paper, not the abstract.

## Sources

- Journal of Clinical Oncology 2012: https://doi.org/10.1200/JCO.2011.38.0402
- PubMed: https://pubmed.ncbi.nlm.nih.gov/22614995/
- Europe PMC: https://europepmc.org/article/MED/22614995

## 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/)
- targets: [CD30](https://onco.cc/targets/cd30/)
- drugs: [Brentuximab vedotin](https://onco.cc/drugs/brentuximab-vedotin/)
- trials: [Brentuximab vedotin phase 2 in relapsed systemic anaplastic large cell lymphoma (SG035-0004)](https://onco.cc/trials/brentuximab-salcl-phase-2/)

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