2022 will see the opening of an international Phase II Clinical Trial at sites across Australia, giving access to two new and promising drugs for children and young adults who relapse with acute lymphoblastic leukaemia (ALL).

The innovative new trial, titled RAVEN, will be the first study to examine the effectiveness of combination treatment to overcome chemotherapy resistance in a large number of children and young people with relapsed ALL.

While more than 80 per cent of children and young people with ALL will be cured with frontline treatment, 10 to 20 per cent of them will relapse.

The international trial, funded equally by the Leukaemia Foundation and Snowdome Foundation, is the first time an ALL trial developed by St Jude Children’s Research Hospital (Memphis, U.S.) will be available Australia-wide.

This is the eighth project Leukaemia Foundation and Snowdome Foundation have co-funded to improve outcomes for blood cancer patients.

The trial will treat ALL-relapsed children and young adults aged four to 21 with a combination of venetoclax, navitoclax and chemotherapy and will recruit up to 78 patients in Australia, New Zealand, and the U.S.

RAVEN is due to open in Australia in the second quarter of 2022 and is expected to recruit participants over the following two years. The trial will be available at:

• Royal Children’s Hospital (VIC)
• Monash Children’s Hospital (VIC)
• Queensland Children’s Hospital (QLD)
• John Hunter Children’s Hospital (NSW)
• Children’s Hospital at Westmead (NSW)
• Sydney Children’s Hospital (NSW) Women’s & Children’s Hospital (SA).

Dr Michael Osborn, consultant paediatric and haematologist/oncologist at the Women’s and Children’s Hospital, will lead this trial.

“High-quality clinical trials are vital to improve clinical care for patients and international partnerships are essential due to the rarity of childhood cancers,” said Dr Osborn.

“Venetoclax has been shown to be highly effective in a number of haematological malignancies in older adults, such as chronic lymphocytic leukemia and certain lymphomas, but with ALL patients, there’s only really been some early Phase I studies. The combination of the two drugs – venetoclax and navitoclax – makes this trial quite unique.

“If it’s shown to be effective, it will offer potential treatments for patients who’ve run out of other options. We anticipate that there will be just over 10 children and young people across Australia per year who would be eligible for this trial but hope that what we learn from this study will benefit many more.”