Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Xencor, Inc.

ClinicalTrials.gov Identifier:

NCT01161511

First received: July 8, 2010

Last updated: May 8, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 8, 2010
Last Updated Date	May 8, 2012
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 12, 2010)	To determine the dose limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01161511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Official Title ^ICMJE	A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Brief Summary	This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study will be 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Intervention ^ICMJE	Drug: XmAb®5574
Study Arm (s)	Experimental: Treatment Intervention: Drug: XmAb®5574
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	27
Estimated Completion Date	January 2013
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01161511
Other Study ID Numbers ^ICMJE	XmAb5574-01
Has Data Monitoring Committee	No
Responsible Party	Xencor, Inc.
Study Sponsor ^ICMJE	Xencor, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Xencor, Inc.
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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