Project Title

An Australasian, phase II, multicentre, randomised, study investigating efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL).

Official Title

An Australasian, phase II, multicentre, randomised, study investigating efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL).

Project Summary

The study is evaluating the efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL).

You may be eligible to join this study if you are aged 65 years and older, have documented CD20+ B-cell CLL according to NCI/IWCLL criteria, previously untreated CLL requiring treatment according to NCI/IWCLL criteria, CIRS score >= 6, an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at screening, able to comply with study protocol procedures and a minimum of 14 months of follow-up, and a life expectancy of at least 6 months.

Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive obinutuzumab (GA101) combined with fludarabine and cyclophosphamide (G-FC3). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Fludarabine will be administered orally, 24mg/m2 day 1-3 cycles 1-6. Cyclophosphamide will be administered orally, 150mg/m2 days 1-3 cycle 1-6. Participants in the second study group will receive GA101 with chlorambucil (G-Clb). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Chlorambucil will be administered orally, 150mg/m2 days 1-3 cycle 1-6. A treatment cycle is 28 days in length. A maximum of 6 cycles of therapy will be administered to each patient.

Blood Disorder

• Chronic Lymphocytic Leukemia

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (globally)

32 participants.

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