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CLL8

Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

Phase 3N = 817NCT00281918

Population
Previously untreated, physically fit patients aged 30 to 81 years with CD20-positive chronic lymphocytic leukaemia.
Design
Randomised (1:1), open-label, phase 3 trial in 190 centres in 11 countries. Six courses every 28 days of fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 on days 1 to 3, with or without rituximab (375 mg/m2 on day 0 of course 1; 500 mg/m2 on day 1 of courses 2 to 6). Primary endpoint PFS; analysis by intention to treat; all randomised patients analysed. The ClinicalTrials.gov enrolment (817) equals the sum of the two paper arms.
Primary endpoint
PFS
Arms
  • FCR (experimental, n = 408): Fludarabine, cyclophosphamide and rituximab, six courses
  • FC (control, n = 409): Fludarabine and cyclophosphamide, six courses
People
Hallek M, German Chronic Lymphocytic Leukaemia Study Group
PFSHR 0.56 (95% CI 0.46–0.69)Δ 36-month PFS+20 pointsOSHR 0.67 (95% CI 0.48–0.92)Δ 36-month OS+4 points
Show the numbers
Results reported for CLL8
EndpointAnalysisFCRFCEffect
PFSITT (all 817 randomised patients analysed)primaryHallek 201065% at 3 y45% at 3 yHR 0.56 (95% CI 0.46–0.69)P<0.0001Progression-free proportions at 3 years after randomisation, as stated in the abstract. Median PFS is given in the full text, which was not opened.
OSITT (all 817 randomised patients analysed)primaryHallek 201087% at 3 y83% at 3 yHR 0.67 (95% CI 0.48–0.92)P=0.01Proportions alive at 3 years after randomisation. Reported in the same publication as the primary analysis; the abstract does not say whether OS was a prespecified secondary endpoint.
Results reported for CLL8
EndpointAnalysisFCRFCEffect
PFSITT (all 817 randomised patients analysed)primaryHallek 201065% at 3 y45% at 3 yHR 0.56 (95% CI 0.46–0.69)P<0.0001Progression-free proportions at 3 years after randomisation, as stated in the abstract. Median PFS is given in the full text, which was not opened.
OSITT (all 817 randomised patients analysed)primaryHallek 201087% at 3 y83% at 3 yHR 0.67 (95% CI 0.48–0.92)P=0.01Proportions alive at 3 years after randomisation. Reported in the same publication as the primary analysis; the abstract does not say whether OS was a prespecified secondary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.560.46–0.69
OS0.670.48–0.92
Primary publication: Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376(9747):1164-74. PubMedDOI

Appears in

Sources

  1. Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376(9747):1164-74.

    PubMedDOI