Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

April 18, 2014 updated by: Xencor, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Ohio
      • Columbus, Ohio, United States, 43202
        • The Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the dose limiting toxicities
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XmAb5574-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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