Clinical Trial: Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymph
Brief Summary: This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.
Detailed Summary:
Sponsor: Seattle Genetics, Inc.
Current Primary Outcome:
- To determine the objective response rate in patients with pcALCL, T-MF, and LyP
- To determine the duration of response in patients treated with SGN-30
- To investigate the toxicity profile of SGN-30
Original Primary Outcome:
- To determine the objective response rate in patients who receive SGN-30 at 2 different dosages
- To determine the duration of response in patients with pcALCL treated with SGN-30
- To investigate the toxicity profile of SGN-30
Current Secondary Outcome:
- To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
- To determine the immunogenicity of SGN-30
Original Secondary Outcome:
- To provide preliminary estimates of disease-free and overall survival rates in pcALCL patients treated with SGN-30
- To determine the immunogenicity of SGN-30 in patients with pcALCL
Information By: Seattle Genetics, Inc.
Dates:
Date Received: December 10, 2004
Date Started: September 2004
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014