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Clinical Trial Summary

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01060904
Study type Interventional
Source Seattle Genetics, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 2010
Completion date September 2012

See also
  Status Clinical Trial Phase
Completed NCT00430846 - Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies Phase 1
Terminated NCT00649584 - A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies Phase 1
Completed NCT00947856 - A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study Phase 2
Completed NCT01026233 - Cardiac Safety Study of Brentuximab Vedotin (SGN-35) Phase 1
Completed NCT00848926 - A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma Phase 2
Completed NCT01026415 - Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) Phase 1
Completed NCT01100502 - A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) Phase 3
No longer available NCT01196208 - A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001