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

Mabtenance

Trial name or title Rituximab versus observation as maintenance therapy in CLL (NCT01118234)
Methods Randomised Phase III study comparing rituximab as maintenance treatment with observation alone in patients with CLL
Randomisation:

  • 2 arms: rituximab versus observation
Participants Inclusion criteria:

  • B‐CLL

  • Age > 18 years

  • ECOG performance status 0 to 2

  • Previous rituximab containing induction treatment of the CLL in first or second line

  • Patient must be in complete remission or partial remission after an induction treatment containing rituximab

  • Life expectancy > 6 months
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

    • TRM

    • CRR

    • MRD

    • AEs


  • will not report:

    • ORR

    • Number of patients discontinuing the study because of drug‐related AEs
Starting date December 2009
Contact information Richard Greil, Prof. Dr. Arbeitsgemeinschaft medikamentöse Tumortherapie
Notes Estimated enrolment: 256
Estimated primary completion date: December 2015
Study status according to ClinicalTrials.gov: this study is currently recruiting participants