Ofatumumab re-treatment and maintenance treatment in patients with CLL
Research type
Research Study
Full title
A single-arm, international, multi-center trial investigating the efficacy and safety of ofatumumab re-treatment and maintenance treatment in patients with B-cell chronic lymphocytic leukemia who progressed following reponse or stable disease after ofatumumab treatment in Hx-CD20-406
IRAS ID
4922
Sponsor organisation
GlaxoSmithKline (GSK)
Eudract number
2008-001507-39
Research summary
B-Cell Lymphocytic Leukaemia (CLL) is a type of cancer that affects a specific type of white blood cell called a B-cell. These cells normally help the body fight infection but in CLL patients these cells grow abnormally and accumulate in the blood, bone marrow, liver, spleen and lymph nodes. GSK/Genmab A/S has recently developed a drug therapy called ofatumumab that specifically targets B-cells for destruction. In previous clinical trials, ofatumumab has shown a good safety profile and significant responses have been seen including rapid and long-lasting B-cell depletion and lymph node reductions. In an ongoing international trial (Hx-CD20-406), ofatumumab is given to CLL patients who are refractory to the drug therapies Alemtuzumab and/ofluarabine. Patients are given 8 once-weekly infusions of ofatumumab followed by 4 once-monthly infusions. At present, the treatment options available to patients after the trial are limited.The trial described in this application is an extension to the Hx-CD20-406 trial. Patients with disease progression after improved or stabilised disease in the Hx-CD20-406 trial will be eligible. Patients will have 8 once-weekly infusions of ofatumumab followed by 24 once-monthly infusions thereafter. The primary aim of the trial is to estimate how effective ofatumumab is as a re-treatment and maintenance therapy.
REC name
Scotland A REC
REC reference
08/MRE00/93
Date of REC Opinion
19 Dec 2008
REC opinion
Further Information Favourable Opinion