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Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

NCT01161511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-04-21

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Xencor, Inc.

    lead INDUSTRY

Principal Investigators

  • John C Byrd, MD · Ohio State University, Columbus, Ohio

  • Farrukh Awan, MD · Georgia Health Sciences University, Augusta, Georgia

  • Ian W Flinn, MD, PhD · Sarah Cannon Research Institute, Nashville, Tennessee

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01161511 on ClinicalTrials.gov