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
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Biological: XmAb5574
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xencor, Inc.:

Primary Outcome Measures:
  • To determine the dose limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT01161511     History of Changes
Other Study ID Numbers: XmAb5574-01
Study First Received: July 8, 2010
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Xencor, Inc.:
CLL
SLL
CD19

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

ClinicalTrials.gov processed this record on July 26, 2014