CompletedPhase 2ACTRN12608000404325

An Australian, phase II , multicentre, randomised, open-label, dose intensification study of three patient cohorts, investigating varying dose schedules, each of 6 x 28day cycles, with monitoring continuing for 12 months into the post treatment period.

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

Sponsor

Australasian Leukaemia and Lymphoma Group

Enrollment

120 participants

Start Date

Dec 10, 2008

Study Type

Interventional

Conditions

Chronic Lymphocytic Leukaemia (CLL)

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.

Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing different dosing schedules of two cancer drugs for people aged 65 and older with chronic lymphocytic leukaemia (CLL), a type of blood cancer. The study aims to find the best combination and dose that is effective while being tolerable for older patients. Participants must have CLL that needs treatment and have not had any prior cancer therapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To investigate the safety and tolerability of fludarabine, cyclophosphamide, and rituximab in previously untreated elderly (=65years old) patients with chronic lymphocytic leukaemia. (CLL). Treatm

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. rituximab Cycle 1: 375 mg/m2 day 0* Cycles 2-6: 500 mg/m2 day 1 (Fludarabine Cyclophosphamide Rituximab: FCR3 and Fludarabine Cyclophosphamide Rituximab FCR 5). Dose schedule is determined via randomisation. Duration is x6 28day cycles. There is no wash out period between cycles.