Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

NCT ID: NCT01161511

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

XmAb5574

Group Type: EXPERIMENTAL

XmAb5574

Intervention Type: BIOLOGICAL

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)

Interventions

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)

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xencor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C Byrd, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University, Columbus, Ohio

Farrukh Awan, MD

Role: PRINCIPAL_INVESTIGATOR

Georgia Health Sciences University, Augusta, Georgia

Ian W Flinn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sarah Cannon Research Institute, Nashville, Tennessee

Locations

Medical College of Georgia

Augusta, Georgia, United States

The Ohio State University

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

References

Woyach JA, Awan F, Flinn IW, Berdeja JG, Wiley E, Mansoor S, Huang Y, Lozanski G, Foster PA, Byrd JC. A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. Blood. 2014 Dec 4;124(24):3553-60. doi: 10.1182/blood-2014-08-593269. Epub 2014 Oct 9.

Reference Type: DERIVED

PMID: 25301708 (View on PubMed)

Other Identifiers

XmAb5574-01

Identifier Type: -

Identifier Source: org_study_id