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Brief Summary

GUIDELINE TITLE

Rituximab in lymphoma and chronic lymphocytic leukemia: a clinical practice guideline.

BIBLIOGRAPHIC SOURCE(S)

  • Imrie K, Stevens A, Meyer R, Hematology Disease Site Group. Rituximab in lymphoma and chronic lymphocytic leukemia: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2005 Dec 22. 46 p. (Evidence-based series; no. 6-8). [65 references]

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • September 11, 2008, Rituxan (Rituximab): Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Lymphoma

  • Previously untreated patients with diffuse large B-cell lymphoma (DLBCL), or a variant of DLBCL (such as mediastinal sclerosing B-cell lymphoma, T-cell-rich B-cell lymphoma, Burkitt-like lymphoma, or intravascular lymphoma), who are candidates for treatment with curative intent and will receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), should receive this therapy in combination with rituximab. This grouping includes patients with untreated DLBCL that has transformed from follicular or other indolent lymphoma.
  • There is insufficient evidence at this time to support or refute treatment with a rituximab-containing chemotherapy regimen in patients who have been previously treated for diffuse DLBCL or a variant of DLBCL.
  • There is insufficient evidence to support combining rituximab with chemotherapy when treating patients with human immunodeficiency virus (HIV)-related lymphoma. These patients may be at an increased risk for life-threatening infections when rituximab is combined with CHOP.
  • Previously untreated patients with follicular or other indolent B-cell-histology lymphoma (such as mantle cell lymphoma, marginal zone lymphoma, and lymphoplasmacytoid lymphoma), excluding small lymphocytic lymphoma (SLL), who are appropriate candidates for chemotherapy, should receive this chemotherapy in combination with rituximab.
  • For previously treated patients with follicular or other indolent B-cell-histology lymphoma (such as mantle cell lymphoma, marginal zone lymphoma, and lymphoplasmacytoid lymphoma), excluding small lymphocytic lymphoma (SLL):
    • Patients who have not previously received rituximab and who are appropriate candidates for chemotherapy should receive this chemotherapy in combination with rituximab.
    • Patients who have previously received rituximab and who have achieved a response of at least one year's duration to the last rituximab administration and who are appropriate candidates for chemotherapy should receive this chemotherapy in combination with rituximab.
  • There is currently insufficient evidence to support or refute the additional use of rituximab as a maintenance therapy in patients who have completed chemotherapy plus rituximab.

Chronic Lymphocytic Leukemia (CLL)

  • There is insufficient evidence at this time to support or refute the use of single-agent rituximab or a rituximab-containing chemotherapy regimen in patients with chronic lymphocytic leukemia (CLL).

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by randomized controlled trials.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Imrie K, Stevens A, Meyer R, Hematology Disease Site Group. Rituximab in lymphoma and chronic lymphocytic leukemia: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2005 Dec 22. 46 p. (Evidence-based series; no. 6-8). [65 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2005 Feb 17 (revised 2005 Dec 22)

GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

GUIDELINE DEVELOPER COMMENT

The Program in Evidence-based Care (PEBC) is a project supported by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

SOURCE(S) OF FUNDING

Cancer Care Ontario
Ontario Ministry of Health and Long-Term Care

GUIDELINE COMMITTEE

Provincial Hematology Cancer Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The members of the Hematology Disease Site Group (DSG) disclosed potential conflicts of interest relating to the topic of this practice guideline. The lead author and citation and evidence reviewer (KI) of this topic was a co -investigator in one trial included in this report and is involved with an ongoing trial on rituximab. Three other DSG members reported research involvement with trials on this topic, of which one member was involved with one trial in this report. In addition, three of the above DSG members, including the lead author, reported involvement with the pharmaceutical company that manufactures rituximab, including research funding, membership on boards of directors or advisory committees, provision of consultancy, or honoraria.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on August 11, 2005. The information was verified by the guideline developer on September 16, 2005. This NGC summary was updated by ECRI on August 18, 2006. The updated information was verified by the guideline developer on August 23, 2006. This summary was updated by ECRI on January 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Rituxan (Rituximab). This summary was updated by ECRI Institute on October 8, 2008 following the U.S. Food and Drug Administration advisory on Rituxan (rituximab).

COPYRIGHT STATEMENT

DISCLAIMER

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