Health Condition 1: null- Untreated Chronic Lymphocytic Leukemia
Conditions
Interventions
Intervention1: ofatumumab + chlorambucil: Drug: ofatumumab (GSK1841157) infusion
iv infusion
dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days
Drug: chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days
duration: minimum of 3 cycles until best response or maximum of 12 cycles
Control Intervention1: Drug: Chlorambucil, tablets: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days
duration: minimum of 3 cycles until best response or maximum of 12 cycles
Sponsors
GlaxoSmithKline Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Diagnosis of CLL defined by: Circulating lymphocytes >=5,000/μL AND Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, CD23, CD79b, and surface Ig prior to Visit 2 Considered inappropriate for fludarabine-based therapy, for reasons that include, but not limited to, advanced age or presence of co-morbidities. Active disease and indication for treatment based on modified NCI-WG guidelines defined by presenting at least any one of the following conditions: (1)Evidence of progressive marrow failure as manifested by development or worsening of anemia and/or thrombocytopenia. (2)Massive (i.e. > 6cm below the left costal margin) or progressive or symptomatic splenomegaly. (3)Massive nodes (i.e. > 10cm in longest diameter) or progressive or symptomatic lymphadenopathy. (4)Progressive lymphocytosis with an increase of more than 50% over a two month period or a lymphocyte doubling time of less than 6 months. A minimum of any one of the following disease-related symptoms must be present: (1)Unintentional Weight loss >= 10% within the previous six months. (2)Fevers > 100.5°F (38.0°C) for >= 2 weeks without evidence of infection. (3)Night sweats for more than 1 month without evidence of infection. (4)Not been previously treated for CLL (prior autoimmune hemolytic anemia treatment permitted). (5)ECOG Performance Status of 0-2. (6)Life expectancy of at least 6 months. Age >= 18 years. Signed written informed consent prior to performing any study-specific procedures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Prior immuno- or chemotherapy for CLL or small lymphocytic lymphoma (SLL) with any agent except corticosteroids used to treat autoimmune hemolytic anemia. Previous autologous or allogeneic stem cell transplantation. Active autoimmune hemolytic anemia requiring corticosteroid therapy more than 100mg equivalent to hydrocortisone or chemotherapy (Subjects can participate if in the opinion of investigator and medical monitor it is thought not to affect the subjectâ??s safety, the conduct of the study or the interpretation of the data). Known CLL transformation (Richter) or CNS involvement or clinically significant cardiac disease. Chronic or current infectious disease requiring systemic antibiotics, antifungal, antiviral treatment. Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible (Subjects can participate if in the opinion of investigator and medical monitor it is thought not to affect the subjectâ??s safety, the conduct of the study or the interpretation of the data). History of significant cerebrovascular disease or event with significant symptoms or sequelae. Glucocorticoid use, unless given in doses Known HIV positive, Positive serology for Hepatitis B (HB). Screening laboratory values: (1)Creatinine more than 2.0 times upper normal limit (unless normal creatinine clearance). (2)Total bilirubin more than 2.0 times upper normal limit (unless due to liver involvement of CLL). (3)Alanine transaminase (ALT) more than 3.0 times upper normal limit (unless due to liver involvement of CLL). (4)Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free-survival (PFS)Timepoint: Time Frame: 259 events, 51.3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate overall survival Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokineticsTimepoint: Time Frame: 259 events, 51.3 months Time Frame: 259 events, 51.3 months Time Frame: 259 events, 51.3 months | — |
Countries
Belgium, Brazil, Canada, Czech Republic, Germany, Greece, India, Ireland, Italy, Netherlands, Poland, Russian Federation, Spain, Sweden, United Kingdom, United States of America
Contacts
Public ContactMr Kedar Nayak
GlaxoSmithKline Pharmaceuticals Limited
Outcome results
None listed