Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

NCT01161511 | Completed Phase 1

• 1 other identifier: XmAb5574-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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

Keywords

CLL; SLL; CD19

Outcome Measures

Primary Outcomes (1)

• To determine the dose limiting toxicities

  28 days

Study Arms (1)

1

EXPERIMENTAL

XmAb5574

Biological: XmAb5574

Interventions

XmAb5574 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)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (3)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 25301708 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 13, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (3)