Chronic Lymphocytic Leukemia Clinical Trial
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Summary
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 leukemia-cll/" >CLL/SLL.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 3 Locations for this study
Augusta Georgia, 30912, United States
Columbus Ohio, 43202, United States
Nashville Tennessee, 37203, United States
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