Back to resultsSafety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XmAb5574
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, SLL, CD19
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
Sites / Locations
- Medical College of Georgia
- The Ohio State University
- Sarah Cannon Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
XmAb5574
Outcomes
Primary Outcome Measures
To determine the dose limiting toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01161511
Brief Title
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
CLL, SLL, CD19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
XmAb5574
Intervention Type
Biological
Intervention Name(s)
XmAb5574
Intervention Description
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)
Primary Outcome Measure Information:
Title
To determine the dose limiting toxicities
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Byrd, MD
Organizational Affiliation
Ohio State University, Columbus, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farrukh Awan, MD
Organizational Affiliation
Georgia Health Sciences University, Augusta, Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian W Flinn, MD, PhD
Organizational Affiliation
Sarah Cannon Research Institute, Nashville, Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25301708
Citation
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.
Results Reference
derived
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Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
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