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A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukaemia, Lymphocytic, Chronic

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Trial Information

A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free-survival (PFS)

Outcome Time Frame:

51 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Institutional Review Board

Study ID:

OMB110911

NCT ID:

NCT00748189

Start Date:

December 2008

Completion Date:

June 2017

Related Keywords:

  • Leukaemia, Lymphocytic, Chronic
  • Oncology
  • Untreated
  • Efficacy
  • Safety
  • Chronic Lymphocytic Leukemia
  • Ofatumumab
  • Chronic Lymphocytic Leukemia (CLL), untreated
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Seattle, Washington  98133