Australian trials offer access to precision therapies for AML and MDS
Australian AML and MDS patients with excess blasts-2 (MDS-EB2) could access novel therapies years ahead of their expected market availability through two international clinical trials.
The HO156/AMLM24 trial will investigate whether midostaurin or gilteritinib can improve survival of newly-diagnosed AML and MDS-EB2 patients with FLT3 gene mutations, when added to intensive chemotherapy. The Australian arm will be headed by Chief Investigator, Associate Professor Andrew Wei from The Alfred Hospital in Melbourne.
Principle Investigator, Professor Paula Marlton, Head of Leukaemia and Deputy Director of Haematology at the Princess Alexandra Hospital will lead the AMLM23 trial’s Australian arm, exploring the impact of adding ivosidenib and enasidenib to standard treatment in newly-diagnosed IDH1 or IDH2-positive AML or MDS-EB2 patients. Both trials are currently recruiting.
Australian participation in the studies is enabled through the Trials Enabling Program (TEP) involving the Australasian Leukaemia & Lymphoma Group (ALLG) in partnership with the Leukaemia Foundation.
Guidelines recommend NIPT for fetal RHD
All rhesus D (RHD) negative pregnant women should receive non-invasive prenatal testing (NIPT) for foetal RHD, according to new guidelines, but limited lab facilities and funding mean Australia can’t yet comply.
The guidelines, released by National Blood Authority Australia, provide recommendations on RHD immunoglobulin use in antenatal prophylaxis, with respect to maternal and foetal RHD status and immunoglobulin supply constraints.
They say NIPT can help identify RHD negative women with RHD positive foetuses who are most likely to require antenatal RHD immunoprophylaxis.
However in a statement Australian Red Cross Lifeblood said it was important to note that Lifeblood has not been approved to provide NIPT for RHD for the purpose of targeted antenatal RhD immunoprophylaxis.
Currently, the Lifeblood Red Cell Reference laboratory is Australia’s sole NATA-accredited RHD NIPT provider and is only approved to supply the test to pregnant women at high risk of RHD haemolytic disease of the foetus and newborn.
“Consequently, the recommendation in the guidelines to use NIPT for RHD to enable targeted antenatal RhD-immunoglobulin prophylaxis will not be able to be implemented in Australia at this point in time,” Lifeblood Medical Director Pathology Services, Dr James Daly, said in a press release.
The Australian Government is considering foetal RHD genotype funding and supply
arrangements, following the Medical Services Advisory Committee’s 2020 assessment.
“In the meantime, clinicians should continue to provide universal antenatal RHD-Ig
immunoprophylaxis using the Care pathway for the prophylactic use of RhD immunoglobulin in pregnancy (excluding non-invasive prenatal testing),” Dr Daly said.
Clinico-pathological spectrum of VITT may be wider than we think
Current guidelines lack the sensitivity to detect early cases of COVID vaccine-induced clotting, which could risk missing or delaying diagnoses, UK researchers warn.
Writing in the British Journal of Haematology they highlight four patients who had Vaccine Induced Thrombotic Thrombocytopenia (VITT) but who, based on current guidance, could have been classified as a low likelihood for the syndrome.
“We believe that the clinico-pathological spectrum associated with VITT may be much wider than first envisaged … with improved awareness of this condition it is more likely that patients may present earlier, while the disorder is still in evolution,” they wrote.
“Physicians should therefore not discount the possibility of VITT in patients with two of the three key features [thrombosis, thrombocytopenia and elevated D-dimers], as this may represent an evolving phenotype,” they conclude.