Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Stopped early · Phase 3

Conditions studied: Leukaemia, Lymphocytic, Chronic

In brief

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

Key facts

Study ID

NCT00748189

Run by

Novartis Pharmaceuticals

People needed

447

Starts

2008-12-22

Expected to finish

2018-05-17

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• prior CLL therapy
• abnormal/inadequate blood values, liver, and kidney function
• certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (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

Where it is running

• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Murrieta, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — New Port Richey, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Ocoee, Florida, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Lee's Summit, Missouri, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Abilene, Texas, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — Midland, Texas, United States
• Novartis Investigative Site — Odessa, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Tyler, Texas, United States
• Novartis Investigative Site — Sedona, Arizona, United States

Full record on ClinicalTrials.gov

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