HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab - Tabular View

Tracking Information

First Received Date ^ICMJE

July 6, 2006

Last Updated Date

July 10, 2009

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of response [ Time Frame: Est Dec 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00349349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

Official Title ^ICMJE

A Single-Arm, International, Multi-Center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-Cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab

Brief Summary

The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

B-Cell Chronic Lymphocytic Leukemia

Intervention ^ICMJE

Drug: ofatumumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

225

Completion Date

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Tumor cell phenotype consistent with B-CLL
Patients with active B-CLL and with an indication for treatment
Failing at least one fludarabine-containing treatment regimen
Failing at least one alemtuzumab-containing treatment regimen
ECOG Performance Status of 0, 1, or 2
Life expectancy of at least 4 months

Exclusion Criteria:

Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
Previous autologous stem cell transplantation within 6 months prior to Visit 2
Allogeneic stem cell transplantation
Radioimmunotherapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00349349

Responsible Party

International Clinical Trial Manager, Genmab A/S

Study ID Numbers ^ICMJE

Hx-CD20-406

Study Sponsor ^ICMJE

Genmab

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Chair:	Anders Österborg, Professor	Karolinska Hospital, Stockholm, Sweden
Study Chair:	William Wierda, Asst. Prof.	M.D. Anderson Cancer Center, Houston, Texas, US

Information Provided By

Genmab

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP