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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.
ClinicalTrials.gov Identifier: NCT01161511
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Biological: XmAb5574 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Primary Completion Date : January 2013
Study Completion Date : January 2013


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
XmAb5574
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)


Outcome Measures

Primary Outcome Measures :
  1. To determine the dose limiting toxicities [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161511


Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43202
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Xencor, Inc.
Investigators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT01161511     History of Changes
Other Study ID Numbers: XmAb5574-01
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by Xencor, Inc.:
CLL
SLL
CD19

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell