Rituximab for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukaemia (TA193)

Technology Appraisal Guidance No. 193

Source: National Institute for Health and Care Excellence

1. Guidance

1.1  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.

1.2  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.

1.3  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.

1.4  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.

1.5  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.


The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA193

An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N2241. It is also available on the Internet at http://guidance.nice.org.uk/TA193/QuickRefGuide/pdf/English

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Trabectedin for the treatment of advanced soft tissue sarcoma
Issue Date: July 2010
Review Date: Dec 2010


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