Health Condition 1: null- Relapsed chronic lymphocytic leukemia
Conditions
Interventions
Intervention1: Ofatumumab: Ofatumumab will be infused intravenously on day 1 (300mg) and day 8 (1000mg) in the first cycle, followed by infusions of 1000mg every 2 months.
Control Intervention1: None:
Sponsors
GlaxoSmithKline Pharmaceuticals Ltd Dr Annie Besant Road Worli Mumbai India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines At least PR according to the revised 2008 NCI-WG CLL criteria within 3 months of the response assessment after the last dose of 2nd/3rd line treatment The anti-leukemic treatment before study entry should have been for at least 3 months or 3 cycles ECOG Performance Status of 0-2 Signed written informed consent prior to performing any study-specific procedures
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Known 1o/2o fludarabine-refractory subjects, defined as treatment (PR/CR) failure or PD within 6 months Prior maintenance therapy Known CLL transformation (Richter), PLL or CNS involvement or CS cardiac disease Active Autoimmune Hemolytic Anemia (AIHA) requiring treatment except if in PI opinion is thought not to affect the subjectâ??s safety, the conduct of the study or the interpretation of the data Previous autologous or allogeneic stem cell transplantation Chronic/current infectious disease requiring systemic antibiotics/antifungal/antiviral treatment Other past or current malignancy (with the exception of with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator 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 Other anti-leukemic use of medications including glucocorticoids Known HIV positive, Positive serology for Hepatitis B (HB). For subjects that are HBsAg -ve, HBcAb +ve and HBV DNA â??ve blood samples will be collected for HBV DNA testing every 2 M during the treatment/observation and during FUP at the 3 M and 6 M visit. Screening laboratory values: Platelets less than50 x 109/L, Neutrophils less than1.0 x 109/L, Creatinine more than 2.0 times ULN (unless CC is normal ) Total bilirubin more than 2.0 times ULN (unless due to liver involvement of CLL) Alanine transaminase (ALT) more than 3.0 times ULN (unless due to liver involvement of CLL) , Alkaline phosphatase more than 2.5 times ULN Lactating women, women with a positive pregnancy test at Visit 1 or women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS)Timepoint: From randomization until disease progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of myelosuppression, frequency of transfusions, Immunoglobulin serum levels, incidence of infections and autoimmune hemolytic anemiaTimepoint: From time of randomization until 60 days after last treatment/observation visit;Improvement in responseTimepoint: From time of randomization to end of study;Overall survivalTimepoint: From time of randomization to date of death (5 year f/u after end of study);Pharmacokinetic- plasma ofatumumab concentrations (ARM A only)Timepoint: From time of first infusion until 6 months after last dose;Progression free survival after next-line therapyTimepoint: From time of randomization until progression or death following next-line therapy;Time to next CLL therapyTimepoint: From time of randomization until to date of of receiving the next CLL treatment | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Democratic People's Republic of Korea, Denmark, Finland, France, Greece, Hungary, India, Ireland, Israel, Italy, Netherlands, Norway, Other, Poland, Russian Federation, Spain, Sweden, Turkey, Ukraine, United States of America
Contacts
Public ContactKedar Nayak
GlaxoSmithKline Pharmaceuticals Ltd.
Outcome results
None listed