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Condition / disease
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Status: Not yet recruiting

HMA-Venetoclax Induction in Newly Diagnosed AML

Acute myeloid leukaemia (AML) is a clonal haematological malignancy characterised by arrested myeloid differentiation and uncontrolled proliferation of blast cells in the bone marrow and peripheral blood. It is the most common acute leukaemia in adults and carries a high disease-related mortality. Globally, the median age of diagnosis is approximately 68 years; however, a significant proportion of patients are diagnosed below the age of 50 years, constituting the 'young fit' population for whom aggressive curative-intent therapy is most appropriate. The epidemiology of AML in South Asia and Pakistan remains incompletely characterised. Published single-centre and multi-centre data from Pakistan suggest that AML represents a major proportion of haematological malignancies presenting to tertiary centres. AFBMTC, as the largest haematology and transplant centre in Pakistan, has accumulated over 2,000 HSCT procedures since 2001 and has established the necessary infrastructure for prospective clinical research in this disease. Cytogenetic and molecular classification of AML profoundly influences prognosis and treatment decisions. The European LeukemiaNet (ELN) 2022 risk stratification framework categorises AML into Favourable, Intermediate, and Adverse risk groups based on chromosomal abnormalities and somatic mutations including NPM1, FLT3-ITD, IDH1/2, RUNX1, ASXL1, TP53, and others. This framework underpins post-remission pathway assignment in the current protocol.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-50Biological sex: AllType: InterventionalSponsor: Pakistan Blood and Marrow Transplant (PBMT) GroupUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Age 18-50 years (inclusive) at the time of enrolment [+11]

Acute promyelocytic leukaemia (APL) [t(15;17); PML-RARA]: patients with APL must... [+16]