Chronic Lymphocytic Leukemia Clinical Trial

Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

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 leukemia-cll/" >CLL/SLL.

View Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT01161511

Recruitment Status:

Completed

Sponsor:

Xencor, Inc.

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There are 3 Locations for this study

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Medical College of Georgia
Augusta Georgia, 30912, United States
The Ohio State University
Columbus Ohio, 43202, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT01161511

Recruitment Status:

Completed

Sponsor:


Xencor, Inc.

How clear is this clinincal trial information?

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