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 (CLL05)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Full data of 149 patients with a poor prognosis of diffuse large b-cell lymphoma was analysed (151 eligible patients - 3 patients withdrawing consent) Safety population analyzed was 151 patients (all patients that received at least 1 dose) ECOG performance status was assessed for all 151 patients (ECOG taken pre-treatment) Objective to demonstrated effectiveness of using PET/CT scanning to determine further treatment post 4 cycles of R-CHOP-14 treatment ○ PET/CT positive patients receiving R-ICE x 3 followed by Z-BEAM/ASCT + IF-RT ○ PET/CT negative patients recevigin R_CHOP-14 x 2 Interim PET response of 143 patients (after 4 cycles of R-CHOP 14 Data of Follow Up of 143 patients went for a minimum length of 0.065 months, and a maximum length of 65.22 (as months since interim PET scan)
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Chemotherapy |

Source Study


Commercial sector/Industry,Roche

Scientific enquiries

Prof Stephen Mulligan

Brief Summary

The trial is a randomised phase II open-label multicentre trial investigating oral fludarabine, cyclophosphamide and intravenous rituximab in previously untreated elderly (= 65 years old) patients with chronic lymphocytic leukaemia. The primary objective is to investigate the tolerability of each of three of these combination chemotherapies and the associated primary endpoint is the proportion of paitens able to complete 6 cycles of therapy.

Key Inclusion Criteria

1. B-CLL confirmed according to National Cancer Institute (NCI) Working Group Criteria. 2. Binet stage B or C, or progressive symptomatic stage A (see Protocol Appendix I). 3. Age = 65 years old. 4. Judged to be in need of systemic therapy (see Protocol Appendix II). 5. No previous treatment (chemotherapy, radiotherapy or immunotherapy) for CLL. 6. Alkaline phosphatase and transaminases = 2 x ULN.(Upper Limits of Normal) 7. Creatinine clearance = 50 ml/min (as calculated by (estimated Glomerular ....
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Key Exclusion Criteria

1. Age < 65 years old. 2. Non-progressive or stable Binet stage A. 3. Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia (as discerned by treating physician). 4. Active second malignancy currently requiring treatment (except for non-melanoma skin cancer or cervical cancer in situ or tumour treated curatively by surgery > 5 years ago) 5. Concomitant disease requiring prolonged use of glucocorticoids (> 1 month). 6. Known hypersensitivity with anaphylactic reaction to ....
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Can healthy volunteers participate?




Sample Size    120

Min. age    65 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Chronic Lymphocytic Leukaemia (CLL)

Condition code    Cancer


Intervention code Treatment: Drugs

To investigate the safety and tolerability of fludarabine, cyclophosphamide, and rituximab in previously untreated elderly (=65years old) patients with chronic lymphocytic leukaemia. (CLL). Treatment Arm1:oral fludarabine 24 mg/m2 days 1-5. plus intravenous (i.v.) rituximab Cycle 1: 375 mg/m2 day 0* Cycles 2-6: 500 mg/m2 day 1 (Fludarabine Rituximab:FR5), Treatment Arm2 and Arm3 :oral fludarabine 24 mg/m2 days 1-3. plus oral cyclophosphamide 150 mg/m2 days 1-3. in varing dose intensity with i.v. ....
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Control group Dose comparison

'There are three cohorts of active treatment. Randomisation arms allocated via randomisation (as described in the description of the interventions)'.


Outcome: The proportion of patients completing 6 treatment cycles
Timepoint: 24 weeks (6 x 28 day cycles)

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see