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Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161511
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Xencor, Inc.

July 8, 2010
July 13, 2010
April 21, 2014
September 2010
January 2013   (Final data collection date for primary outcome measure)
To determine the dose limiting toxicities [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01161511 on Archive Site
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Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Biological: XmAb5574
Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22)
Experimental: 1
Intervention: Biological: XmAb5574
Woyach JA, Awan F, Flinn IW, Berdeja JG, Wiley E, Mansoor S, Huang Y, Lozanski G, Foster PA, Byrd JC. A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. Blood. 2014 Dec 4;124(24):3553-60. doi: 10.1182/blood-2014-08-593269. Epub 2014 Oct 9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Not Provided
Xencor, Inc.
Xencor, Inc.
Not Provided
Principal Investigator: John C Byrd, MD Ohio State University, Columbus, Ohio
Principal Investigator: Farrukh Awan, MD Georgia Health Sciences University, Augusta, Georgia
Principal Investigator: Ian W Flinn, MD, PhD Sarah Cannon Research Institute, Nashville, Tennessee
Xencor, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP