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

CHRUT‐LLC‐2007‐SA

Trial name or title Fludarabine, cyclophosphamide, and rituximab followed by rituximab or observation in treating older patients with previously untreated CLL (NCT00645606)
Methods Maintenance after combined induction immunochemotherapy with FluC‐R in patients older than 65 years with previously untreated B‐CLL
Randomisation:

  • 2 arms: rituximab versus observation
Participants Inclusion criteria:

  • diagnosis of B‐CLL, Binet stage B or C (Rai stage III or IV)

  • no 17p‐deletion by FISH (> 10% positive cores)

  • life expectancy > 6 months

  • ECOG performance status 0 or 1

  • no severe co‐morbidities

  • CIRS < 6

  • no previous treatment for CLL by chemotherapy, radiotherapy or immunotherapy
Interventions Arm 1: rituximab
Arm 2: observation
Outcomes Outcomes and time points from the registered protocol of the study that are considered in the review:

  • will report:

    • OS

    • PFS

    • time to next treatment

    • CRR

    • ORR

    • AEs


  • will not report:

    • TRM

    • MRD

    • number of patients discontinuing the study because of drug‐related AEs
Starting date November 2007
Contact information Caroline Dartigeas, MD Centre Hospitalier Universitaire Bretonneau de Tours
Notes Estimated enrolment: 304
Estimated primary completion date: August 2012
Study status according to ClinicalTrials.gov: this study is currently recruiting participants