Status:
COMPLETED
Ofatumumab With Fludarabine and Cyclophosphamide in B-CLL Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with B-CLL
Eligibility Criteria
Inclusion
- Patients with active B-CLL and with an indication for treatment
- Age ≥ 18 years
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Exclusion
- Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL
- Glucocorticoid unless given in doses ≤ 10 mg /day for other indications than B-CLL (e.g. asthma)
- Known transformation of B-CLL
- Known CNS involvement of B-CLL
- Past or current malignancy, except for:
- Cervical carcinoma Stage 1B or less
- Non-invasive basal cell and squamous cell skin carcinoma
- Malignant melanoma with a complete response of a duration of \> 10 years
- Other cancer diagnoses with a complete response of a duration of \> 5 years
- Chronic or current infectious disease requiring systemic treatment
- Clinically significant cardiac disease
- Significant concurrent, uncontrolled medical condition
- History of significant cerebrovascular disease
- Known HIV positive
- Positive serology for hepatitis B, unless due to vaccination
- Leukapheresis, except as a safety measure before chemotherapy
- ECOG Performance Status of 3 or 4
- Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen
- Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
- Current participation in any other interventional clinical study
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Breast feeding women or women with a positive pregnancy test at Visit 1
- Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00410163
Start Date
January 1 2007
End Date
May 1 2013
Last Update
February 10 2014
Active Locations (2)
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1
GSK Investigational Site
Houston, Texas, United States, 77030
2
GSK Investigational Site
Plymouth, Devon, United Kingdom, PL68DH