Professor Stephen Mulligan
Australasian Leukaemia & Lymphoma Group (ALLG)
CLL7 clinical trial
Recipient: Professor Stephen Mulligan
Institute: Royal North Shore Hospital (NSW)
title: Australasian, Phase II, multicentre, randomised
study of efficacy and safety for dose reduced
fludarabine,cyclophosphamide and intravenous
obinutuzumab compared to oral chlorambucil
and obinutuzumab in previously untreated,
comorbid, elderly (≥65 years) patients with chronic
Disease focus: Chronic lymphocytic leukaemia
Funding period: 2015-2017
Sydney-based haematologist, Professor Stephen Mulligan, is leading an Australian clinical trial to investigate a potential new treatment schedule for older patients with chronic lymphocytic leukaemia (CLL).
The Australasian Leukaemia & Lymphoma Group (ALLG) is running the trial to compare the benefits in treating CLL patients, aged 65 years or older, with the next generation anti-CD20 antibody, obinutuzumab, in combination with either two chemotherapy drugs, fludarabine and cyclophosphamide; or the chemotherapy drug chlorambucil.
Obinutuzumab is marketed in Australia as GazyvaTM, and belongs to the same class of drugs as rituximab (also known as MabThera®).
In January 2014, the results were published from an international Phase III trial, in which elderly CLL patients who also had other health conditions were treated with obinutuzumab in combination with chlorambucil. These patients had a better overall survival than those who received chlorambucil alone, and were more likely to have all signs of their disease disappear.
Until recently, chlorambucil was considered the gold standard of treatment for elderly CLL patients. However, in a recent ALLG CLL5 clinical trial, Australian researchers demonstrated that rituximab in combination with fludarabine and cyclophosphamide was a safe, tolerable and effective treatment for fit, elderly patients. Following the trial, this combination became the new standard of care in Australia.
With the release of the data from the international CLL trial, the ALLG now wants to know if obinutuzumab plus fludarabine and cyclophosphamide is tolerable and even more effective in this patient population than rituximab.
Professor Mulligan says it’s an important question to answer in this rapidly changing landscape of monoclonal and molecular therapies.
“Elderly CLL patients with comorbidities (additional illnesses) currently have no standard of care. The outcome of this CLL7 trial, taken together with other international trials underway, will lead to an established standard for this group of patients,” Professor Mulligan said.
The CLL7 trial will run over three years, involving 120 patients treated at 30 accredited ALLG sites across Australia. Professor Mulligan expects the outcomes of the trial to be translated into clinical practice.
Professor Mulligan is widely regarded as pioneering CLL research in Australia for nearly two decades. He received a 2011 Leukaemia Foundation Grant-in-Aid