Ofatumumab versus Physicians' Choice in BFR chronic CLL

• Research type

  Research Study

• Full title

  An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy versus Physicians' Choice in Patients with Bulky Fludarabine Refractory Chronic Lymphocytic Leukaemia (CLL)

• IRAS ID

  62645

• Contact name

  Anna Schuh

• Sponsor organisation

  GlaxoSmithKline UK

• Eudract number

  2010-023066-52

• ISRCTN Number

  na

• Research summary

  Chronic Lymphocytic Leukaemia (CLL or B-CLL) is a chronic leukaemia in which clonal B-cells progressively accumulate. It is the most common type of leukaemia in the western world. Overall survival times ranging from months to decades. Median survival from diagnosis is approximately 10 years, but is only 18 months for patients with advanced disease and 9-13 months for CLL cases refractory tfluarabine.OMB114242 is an open-label, two-arm, randomized, Phase III study to evaluate an improvement in progression free survival (PFS) with Ofatumumab treatment versus physicians?? choice (PC) in patients with chronic lymphocytic leukaemia (CLL) refractory tfluarabine and who have bulky lymphadenopathy with at least one lymph node > 5 cm requiring therapy. The study comprises of three study periods: the Screening Period, the Study Treatment Period; eligible patients will be randomized in a 2:1 ratio to receive either:(Arm A) Non-Ofatumumab containing regimen as per physicians?? choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care in the UK, or (Arm B), Ofatumumab at an initial dose of 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of Ofatumumab, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 2000 mg Ofatumumab per 4 weeks for up to 24 weeks, or no further therapy (observation only). The third phase is the survival and disease status assessments every 4 weeks for Months 1 to 6, every 8 weeks for Months 7 to 12, and every 3 months up to Month 60

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0063

• Date of REC Opinion

  26 Apr 2011

• REC opinion

  Further Information Favourable Opinion