Status:
COMPLETED
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects 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 fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Detailed Description
Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine a...
Eligibility Criteria
Inclusion
- Key
- confirmed and active CLL requiring treatment
- at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
- 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
- Key
Exclusion
- diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
- abnormal/inadequate blood values, liver and kidney function
- certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
- active or chronic infections
- use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
- 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 :
March 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2017
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00824265
Start Date
March 12 2009
End Date
October 25 2017
Last Update
June 18 2020
Active Locations (135)
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1
Novartis Investigative Site
Boca Raton, Florida, United States, 33486
2
Novartis Investigative Site
Chicago, Illinois, United States, 60612-3833
3
Novartis Investigative Site
Clinton, Maryland, United States, 20735
4
Novartis Investigative Site
Kansas City, Missouri, United States, 64128