Text Size

Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT01161511
First received: July 8, 2010
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study will be 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
 Drug: XmAb®5574
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: XmAb®5574

  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
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.
  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: May 8, 2012
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 June 18, 2013