NICE, The UK Regulator Publishes Guidance on Rituximab for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukaemia.

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Rituximab in combination with fludarabine and cyclophosphamide is recommended as a treatment option for people with relapsed or refractory chronic lymphocytic leukaemia except when the condition:
• is refractory to fludarabine (that is, it has not responded to fludarabine or has relapsed within 6 months of treatment) or
• has previously been treated with rituximab, unless:
− in the context of a clinical trial, at a dose lower than the dose currently licensed for chronic lymphocytic leukaemia or
− in the context of a clinical trial, in combination with chemotherapy other than fludarabine and cyclophosphamide.

Rituximab in combination with fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia that has previously been treated with rituximab, unless rituximab has been given as specified in section 1.1.

Rituximab in combination with chemotherapy other than fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia.

People with chronic lymphocytic leukaemia that is refractory to fludarabine (as defined in section 1.1), who are currently receiving rituximab in combination with fludarabine and cyclophosphamide should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

People with chronic lymphocytic leukaemia that has previously been treated with rituximab other than as specified in section 1.1, who are currently receiving rituximab in combination with fludarabine and cyclophosphamide and people who are currently receiving rituximab in combination with other chemotherapy regimens that is not in the context of research, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

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