Status:
COMPLETED
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Lead Sponsor:
Xencor, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 furt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01161511
Start Date
September 1 2010
End Date
January 1 2013
Last Update
April 21 2014
Active Locations (3)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
The Ohio State University
Columbus, Ohio, United States, 43202
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203