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Trial record 1 of 1 for:    XmAb5574-01
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Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT01161511
First received: July 8, 2010
Last updated: April 18, 2014
Last verified: April 2014

July 8, 2010
April 18, 2014
September 2010
January 2013   (final data collection date for primary outcome measure)
To determine the dose limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01161511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
XmAb5574
Intervention: Biological: XmAb5574
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01161511
XmAb5574-01
No
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