Spots Global Cancer Trial Database for Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Official Title: A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Study ID: NCT01161511
Interventions
Study Description
Brief 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 CLL/SLL.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical College of Georgia, Augusta, Georgia, United States
The Ohio State University, Columbus, Ohio, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Contact Details
Name: John C Byrd, MD
Affiliation: Ohio State University, Columbus, Ohio
Role: PRINCIPAL_INVESTIGATOR
Name: Farrukh Awan, MD
Affiliation: Georgia Health Sciences University, Augusta, Georgia
Role: PRINCIPAL_INVESTIGATOR
Name: Ian W Flinn, MD, PhD
Affiliation: Sarah Cannon Research Institute, Nashville, Tennessee
Role: PRINCIPAL_INVESTIGATOR
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