Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.

Key facts

Study ID

NCT01161511

Run by

Xencor, Inc.

People needed

27

Starts

2010-09-01

Expected to finish

2013-01-01

Last updated by the study team

2014-04-21

Who can join

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

You may qualify if…

• relapsed or refractory CLL/SLL
• at least 18 years of age
• able to receive outpatient treatment and follow-up at the treating institution
• completed all CLL therapies > 4 weeks prior to first study dose

You may not qualify if…

• previously treated with an anti-CD19 antibody therapy
• undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease
• active Richter's syndrome
• designated Class III or IV by the New York Heart Association (NYHA) criteria
• history of myocardial infarction or stroke within the last 6 months
• active viral, bacterial, or systemic fungal infection requiring treatment
• HIV or Hepatitis C positive
• Hepatitis B infection

Where it is running

• Medical College of Georgia — Augusta, Georgia, United States
• The Ohio State University — Columbus, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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