Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00748189

Purpose

The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, 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

Resource links provided by NLM:

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

Drug Information available for: Ofatumumab Chlorambucil

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

progression-free-survival (PFS) [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall response rate [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]
Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	444
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2018
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ofatumumab + chlorambucil: Experimental ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles	Drug: ofatumumab (GSK1841157) infusion iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; Drug: chlorambucil, tablets 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
chlorambucil: Active Comparator chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles	Drug: chlorambucil, tablets 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

Detailed Description:

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.

Eligibility

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

Criteria

Inclusion Criteria:

confirmed CLL diagnosis and active CLL requiring treatment
considered inappropriate for fludarabine-based therapy
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
age 18yrs or older
signed written informed consent

Exclusion Criteria:

prior CLL therapy
abnormal/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 central nervous system involvement
current participation in other clinical study
inability to comply with the protocol activities
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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 115 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OMB110911, EudraCT 2008-004932-19
Study First Received:	September 5, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00748189 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Untreated
Chronic Lymphocytic Leukemia
Ofatumumab

Oncology
Safety
Efficacy

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell

Chlorambucil
Antineoplastic Agents, Alkylating
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell
Alkylating Agents

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Chlorambucil
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Antineoplastic Agents, Alkylating
Leukemia, B-Cell
Lymphoproliferative Disorders
Alkylating Agents

ClinicalTrials.gov processed this record on September 11, 2009