Status:
TERMINATED
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukaemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2018
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00748189
Start Date
December 22 2008
End Date
May 17 2018
Last Update
June 25 2019
Active Locations (154)
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1
Novartis Investigative Site
Sedona, Arizona, United States, 86336
2
Novartis Investigative Site
Tucson, Arizona, United States, 85704
3
Novartis Investigative Site
Murrieta, California, United States, 92562
4
Novartis Investigative Site
Aurora, Colorado, United States, 80012