RAVEN: A phase I/II trial treating relapsed acute lymphoblastic leukemia with venetoclax and navitoclax

Every year, approximately a quarter of all childhood cancers are acute lymphoblastic leukaemia (ALL) and lymphoma. Existing chemotherapy protocols will cure the majority of these patients, however 10-20% of children will experience a relapse, that is, the return of their cancer or their cancer does not respond to treatment (refractory). The outcomes for these children are poor and an early relapse (within 3 years from their diagnosis) is an indication that their long term prognosis is poor.

In order to improve the prognosis for these children, researchers wish to refine the current chemotherapy treatment and are investigating whether the addition of two chemotherapy drugs, venetoclax and navitoclax, will be beneficial to them.

Venetoclax is a new anti-cancer drug, co-developed and trialled at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Victoria. It has already shown outstanding results in several clinical trials including triggering remission in patients with advanced forms of leukaemia for whom treatment options had been exhausted (including ALL). Both venetoclax and navitoclax were largely developed in Australia by researchers at the WEHI.

RAVEN is a phase I/II clinical trial evaluating the activity of venetoclax and navitoclax in conjunction with existing chemotherapy for children with relapsed or refractory acute lymphoblastic leukaemia or lymphoma.  The initial data provided by this clinical trial will be used to determine the safety of the use of these drugs for children with relapsed and refractory ALL and lymphoma.

RAVEN will test the safety of these drugs in children and provide initial data regarding their effectiveness to treat children with relapsed and refractory ALL and lymphoma.

Disease stage: Relapsed or refractory

Patient age range: 4 to 21 years of age

Trial Sponsors:

• National – ANZCHOG
• International – St Jude Children’s Research Hospital, Memphis (U.S.)