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

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
Leukaemia, Lymphocytic, Chronic	Drug: chlorambucil, tablets Drug: ofatumumab (GSK1841157) infusion	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Chlorambucil Ofatumumab

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

progression-free-survival (PFS) [ Time Frame: 51 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall response rate [ Time Frame: 51 months ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 51 months ] [ Designated as safety issue: No ]
Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics [ Time Frame: 51 months ] [ Designated as safety issue: Yes ]
overall survival - EOS [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment:	447
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2017
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ofatumumab + chlorambucil 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: 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 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; Other Names: ofatumumab (GSK1841157) infusion chlorambucil tablets
Active Comparator: chlorambucil 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 requiring treatment, 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

Show 113 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00748189 History of Changes
Other Study ID Numbers:	OMB110911
Study First Received:	September 5, 2008
Last Updated:	April 25, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Oncology
Untreated
Efficacy
Safety

Chronic Lymphocytic Leukemia
Ofatumumab
Chronic Lymphocytic Leukemia (CLL), untreated

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Chlorambucil
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013

Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia (COMPLEMENT 1)