A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Leukaemia, Lymphocytic, Chronic
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 |
