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. 2012 Nov 14;2012(11):CD008079. doi: 10.1002/14651858.CD008079.pub2

Foa 2010

Trial name or title A phase II study of chlorambucil plus rituximab followed by maintenance versus observation in elderly patients with previously untreated chronic lymphocytic leukaemia
Methods Randomisation:

  • RCT with 2 arms: arm 1: maintenance therapy rituximab, arm 2: observation


Median follow‐up time:

  • not reported
Participants Eligibility criteria:

  • Older patients

  • CD20+ CLL requiring therapy according to the IWCLL criteria

  • no previous treatment for CLL


Patients recruited (N = 97; presented data based on interim analysis with first 54 patients):

  • recruitment stratified by treatment arm not provided (6 patients were not available for response: 1 investigator's decision, 2 because of AEs, 3 because of SAEs)


Mean age (interim analysis of the first 54 patients):

  • median age: 70.5 years (range 61‐84 years)


Gender (male, female ‐ interim analysis of the first 54 patients):

  • N = 38, N = 16


Stage of disease (interim analysis of the first 54 patients):

  • stage stratified by treatment arm not provided

  • stage for recruited population (Binet A 25.9%, Binet B 57.4%, Binet C 16.7%)


Country:

  • 19 Italian centres
Interventions All patients received: Clb (up to 8 courses, every 28 days) of 8 mg/m2/day PO on days 1 to 7 combined with 375 mg/m2 rituximab for cycle 3 and 500 mg/m2 for cycles 4 to 8
Responsive patients were randomised to:

  • Arm 1 (2 years' maintenance): rituximab (375 mg/m2 every 2 months)

  • Arm 2: observation
Outcomes Outcomes and time points from the study that are considered in the review:

  • reported:

    • OS

    • PFS

    • CRR

    • ORR

    • AEs

    • number of patients discontinuing the study because of drug‐related AEs


  • not reported:

    • TRM

    • time to next treatment

    • MRD
Starting date Recruitment period:

  • October 2008 and January 2010
Contact information Robin Foa, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy
Notes The authors stated the following disclosures:

  • Foa: Roche ‐ Consultancy, Speakers Bureau

  • Montillo: Roche ‐ Membership on an entity's Board of Directors or advisory committees, Speakers Bureau

  • Runggaldier: Roche employment

  • Gamba: Roche employment