Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic

In brief

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Key facts

Study ID

NCT00430846

Run by

Seagen Inc.

People needed

45

Starts

2006-11-01

Expected to finish

2009-07-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed CD30-positive hematologic malignancy.
• Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
• Patients must have measurable disease of at least 10mm as documented by radiographic technique.
• Must be at least 18 years of age.

You may not qualify if…

• Patients with current diagnosis of pcALCL (systemic ALCL eligible).
• Patients with history of allogeneic stem cell transplant.
• Patients who have had previous treatment with any anti-CD30 antibody.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Washington University — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• University of Texas/MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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