Health Condition 1: null- Relapsed Chronic Lymphocytic Leukemia
Conditions
Interventions
Intervention1: Ofatumumab, Fludarabine, Cyclophosphamide: Drug: OFC Infusion
Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days
Sponsors
GlaxoSmithKline Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, CD23, CD79b, and surface Ig prior to Visit 2 Active disease and indication for treatment based on modified IWCLL updated NCIWG guidelines defined by presenting at least one of the following conditions: Evidence of progressive marrow failure as manifested by development of, or worsening of anemia, and/or thrombocytopenia Massive (i.e., greater than 6 cm below the left costal margin) or progressive or symptomatic splenomegaly Massive nodes (i.e., greater than 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Progressive lymphocytosis with an increase of more than 50% over a 2 month period or lymphocyte doubling time of less than 6 months A minimum of any one of the following disease-related symptoms must be present: Unintentional weight loss more than or equal to 10% within the previous 6 months Fevers >100.5ºF (38.0ºC) for >= 2 weeks without other evidence of infection Night sweats for more than 1 month without evidence of infection Relapsed CLL: defined as a subject who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of >= 6 months, demonstrate evidence of disease progression [Hallek, 2008] ECOG Performance Status of 0-2 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: Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last anti-leukemic therapy [Hallek, 2008] Subjects with platelet count less than 50,000/microliter and ANC 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/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: Creatinine more than 2.0 times upper normal limit (unless normal creatinine clearance) Total bilirubin more than 2.0 times upper normal limit (unless due to liver involvement of CLL) Alanine transaminase (ALT) more than 3.0 times upper normal limit (unless due to liver involvement of CLL) Lactating women, women with a positive pregnancy test at Visit 1 or women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free-survivalTimepoint: Time Frame: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics.Timepoint: Time Frame: 3 years | — |
Countries
Brazil, Bulgaria, Canada, Germany, Greece, India, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States of America
Contacts
Public ContactKedar Nayak
GlaxoSmithKline Pharmaceuticals Ltd.
Outcome results
None listed