Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161511
• Other study ID #: XmAb5574-01
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2010
• Last updated: April 18, 2014
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

Intervention

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)

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	The Ohio State University	Columbus	Ohio
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Xencor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the dose limiting toxicities		28 days	Yes