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Patient Fitness in AML
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Infection and Veno-occlusive disease (VOD)
Haemorrhage and thrombocytopenia
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in ALFA-0701 were thrombocytopenia, VOD, haemorrhage and infection.1
Fatal outcomes:
**Including fatal outcome
Fatal outcomes:
**Including fatal outcomes. The 2 VOD events in the chemotherapy arm occurred after MYLOTARG re-treatment for relapse
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA-0701 study.
Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection
The rate of haemorrhage was higher with MYLOTARG+ chemotherapy vs chemotherapy alone1
MYLOTARG + chemotherapy arm:
The most frequent Grade 3 bleeding/haemorrhagic reactions were haematemesis (3.1%), haemoptysis (3.1%) and haematuria (2.3%)
Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage and pulmonary alveolar haemorrhage [2 patients])
Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma and subdural haematoma)
*Only selected safety data were collected in this study of newly diagnosed AML
**Including fatal outcome
MYLOTARG + chemotherapy arm:
The median time to recovery of platelets (50x109/L) following induction phase was 34 days
*Only selected safety data were collected in this study of newly diagnosed AML
†Thrombocytopenia with platelet counts <50x109/L persisting 45 days after the start of therapy for responding patients (CR and CRp).
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study
Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.
AML; Acute Myeloid Leukaemia; CR, complete remission; CRp, complete remission with incomplete platelet recovery; DGH, District General Hospital; NICE, National Institute for Health and Care Excellence
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