Skip to content
Bending the Curve Trial by Trial
?

SGN-35 phase 1

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies

Phase 1N = 45NCT00430846

Population
45 patients with relapsed or refractory CD30-positive haematological cancers (median of three previous regimens; 73% had undergone autologous stem-cell transplantation).
Design
Phase 1, open-label, multicentre dose-escalation study of brentuximab vedotin (SGN-35) 0.1 to 3.6 mg per kilogram every 3 weeks in relapsed or refractory CD30-positive haematological cancers, primarily Hodgkin lymphoma and anaplastic large-cell lymphoma.
Arms
  • Brentuximab vedotin (experimental, n = 45): Brentuximab vedotin 0.1 to 3.6 mg per kilogram every 3 weeks (dose escalation)
People
Younes A
Show the numbers
Results reported for SGN-35 phase 1
EndpointAnalysisBrentuximab vedotinControlEffect
ORRPatients who received the 1.8-mg-per-kilogram dose (12 patients)primaryYounes 201050%—6 of 12 patients had an objective response at the 1.8 mg per kilogram dose, which was the maximum tolerated dose. Across all 45 patients, objective responses (including 11 complete remissions) were observed in 17 patients. Mixed CD30-positive population, not limited to Hodgkin lymphoma.
Results reported for SGN-35 phase 1
EndpointAnalysisBrentuximab vedotinControlEffect
ORRPatients who received the 1.8-mg-per-kilogram dose (12 patients)primaryYounes 201050%—6 of 12 patients had an objective response at the 1.8 mg per kilogram dose, which was the maximum tolerated dose. Across all 45 patients, objective responses (including 11 complete remissions) were observed in 17 patients. Mixed CD30-positive population, not limited to Hodgkin lymphoma.
Primary publication: Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010;363(19):1812-21. PubMedDOI

Appears in

Sources

  1. Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010;363(19):1812-21.

    PubMedDOI