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

This study is ongoing, but not recruiting participants.

First Received: July 6, 2006 Last Updated: July 10, 2009 History of Changes

Sponsor:	Genmab
Collaborator:	GlaxoSmithKline
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00349349

Purpose

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

Condition	Intervention	Phase
B-Cell Chronic Lymphocytic Leukemia	Drug: ofatumumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab Ofatumumab

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:

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

Estimated Enrollment:	225
Study Start Date:	June 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349349

Show 70 Study Locations

Sponsors and Collaborators

Genmab

GlaxoSmithKline

Investigators

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

More Information

No publications provided

Responsible Party:	Genmab A/S ( International Clinical Trial Manager )
Study ID Numbers:	Hx-CD20-406
Study First Received:	July 6, 2006
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00349349 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genmab:

B-CLL

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Pharmacologic Actions
Leukemia
Lymphatic Diseases

Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Alemtuzumab
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 09, 2009