Anaplastic Large-Cell Lymphoma Clinical Trial
Official title:
A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma
To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease
and anaplastic large cell lymphoma (ALCL).
As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed
per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of
HD patients.
SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has
specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is
expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma.
This study is designed to define the toxicity profile and antitumor activity of SGN-30 in
patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent
anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of
SGN-30 followed by a 4 week observation period.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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