Ofatumumab-Chlorambucil Combination vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

This study is not yet open for participant recruitment.

Verified by GlaxoSmithKline, September 2008

Sponsors and Collaborators:	GlaxoSmithKline Genmab
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00748189

Purpose

Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study is to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: chlorambucil, tablets Drug: ofatumumab (GSK1841157) infusion	Phase III

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

Drug Information available for: Chlorambucil Ofatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

median progression-free-survival (PFS) of ofatumumab added to chlorambucil therapy vs. chlorambucil therapy

Secondary Outcome Measures:

clinical benefit, safety, tolerability, changes in patient reported outcome measures (PRO) and pharmacokinetics

Estimated Enrollment:	444
Study Start Date:	September 2008

Eligibility

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

Criteria

Inclusion Criteria:

confirmed and active CLL requiring treatment
not been treated for CLL before
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours

Exclusion Criteria:

prior CLL therapy
inadequate blood values, liver and kidney function
certain heart problems, active or chronic infections, serious significant diseases, AIHA, other current cancer or within last 5 years
CLL transformation
CLL CNS involvement
current participation in other clinical study
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748189

Locations

United States, California
GSK Clinical Trials Call Center
Illinois, California, United States, 60612

Sponsors and Collaborators

GlaxoSmithKline

Genmab

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	OMB110911, EudraCT 2008-004932-19
Study First Received:	September 5, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00748189
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Untreated
Chronic Lymphocytic Leukemia
Ofatumumab

Oncology
Safety
Efficacy

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell
Chlorambucil
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009