Skip to main content
. 2012 Nov 14;2012(11):CD008079. doi: 10.1002/14651858.CD008079.pub2

Zagoskina 2011

Trial name or title Rituximab therapy of chronic lymphocytic leukaemia patients in remission
Methods Randomisation:

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


Median follow‐up time:

  • not reported
Participants Eligibility criteria:

  • Patients in remission after FluC‐R (N = 117) or FluC (N = 96) (no further information provided)


Patients included 213 patients in remission:

  • observation (N = 133)

  • rituximab (N = 60)


Mean age:

  • 59 years (range: 34 to 76 years)


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

  • not reported


Stage of disease:

  • not reported


Country:

  • Russian (number of centres not reported)
Interventions All patients received either FluC‐R or FluC alone to introduce remission
Arm 1: observation
Arm 2: rituximab therapy in the form of 4 weekly injections (375 mg/m2) every 6 months over 2 years
Outcomes Outcomes and time points from the study that are considered in the review:

  • will report:

    • PFS

    • AEs


  • not reported:

    • OS

    • TRM

    • time to next treatment

    • MRD

    • CRR

    • ORR

    • number of patients discontinuing the study because of drug‐related AEs
Starting date Recruitment period:

  • not reported
Contact information P Zagoskina, Kirov Scientific Research Institute of Hematology and Blood Transfusion of FMBA, Kirov, Russian Federation
Notes The abstract provided no declaration on authors' conflicts of interest

AIHA: autoimmune haemolytic anaemia; B‐CLL: B‐cell chronic lymphocytic leukaemia; CIRS: cumulative illness rating scale; Clb: chlorambucil; CLL: chronic lymphocytic leukaemia; CR: complete response; CRR: complete response rate; CT: computerised tomography; CVP: cyclophosphamide plus vincristine plus prednisolone; ECOG: Eastern Cooperative Oncology Group; FluC: fludarabine plus cyclophosphamide; FCO: fludarabine plus cyclophosphamide plus ofatumumab; FluC‐R: fludarabine plus cyclophosphamide plus rituximab; FISH: fluorescence in situ hybridisation; GCib: RO5072759 plus chlorambucil; ITP: immune thrombocytopenic purpura; IV: intravenous; IWCLL: International Workshop on Chronic Lymphocytic Leukemia; MRD: minimal residual disease; NCI‐WG: National Cancer Institute‐Working Group; nPR: nodular partial response; ORR: overall response rate; OS: overall survival; PFS: progression‐free survival; PLL: prolymphocytic leukaemia; PO: per os; PR: partial response; RClb: rituximab plus chlorambucil; RCT: randomised controlled trial; SAE: serious adverse event; SC: subcutaneous; SLL: small lymphocytic lymphoma; TRM: treatment‐related mortality.