An Australasian, phase II, multicentre, randomised, dose intensification study investigating oral fludarabine, oral cyclophosphamide and i.v. rituximab (poFCivR) tolerance in previously untreated elderly (≥ 65 years old) patients with chronic lymphocytic leukaemia (CLL)

DOI number 10.58109/ewkd-zf39
Publisher Australasian Leukaemia and Lymphoma Group (ALLG)
Creator(s)

Australasian Leukaemia and Lymphoma Group (ALLG)

Stephen Mulligan (Royal North Shore Hospital)
Date Made Available 2023
Dataset Individual participant data (IPD) in aggregate form
Description of Dataset

Dataset includes:

  • Data for 116 elderly (=/>65 y.o.) patients with Chronic Lymphocytic Leukemia (120 patients registered, 117 patients eligible for treatment, 116 received protocol treatment and data included in main analysis)
  • 6 months of treatment data of 116 patients in 3 cohorts:
    • Fludarabine and oral cyclophosphamide,
    • Fludarabine and cyclophamide with iv rituximab
    • Fludarabine and cyclophamide (of higher dose than second cohort) with IV rituximab
  • Follow up data complete for 114 patients for the minimum of 12 months
  • QoL of 104 patients was complete enough to include in analysis (from baseline, cycle 3, cycle 6, Final stage, Follow up 3,6,9 and 12 months)
  • Comparison of tolerance of different dosage, and addition of rituximab
  • Primary endpoint being proportion of patients completed all 6 cycles
  • Treatment delivery and tolerability data for 116 patients
Funding

Australasian Leukaemia and Lymphoma Group (ALLG)
Subject (ANZSRC Category)

Chemotherapy
ANZCTR Reference ACTRN12608000404325
Publication(s)
Dataset Access

Access can be requested via the Health Data Australia catalogue. Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to info@allg.org.au
Memberships
Participate in a Trial
Memberships
Clinical Trials & Research
SC01
MM18