Venetoclax plus high-dose cytarabine and mitoxantrone as salvage treatment for relapsed or refractory acute myeloid leukaemia (RELAX): a multicentre, single-arm, phase 1/2 trial - PubMed

5 days ago

Venetoclax combined with high-dose cytarabine and mitoxantrone was evaluated as salvage treatment for relapsed or refractory acute myeloid leukemia (AML).
The study was a multicentre, single-arm, phase 1/2 trial involving 55 patients aged 18-75 years.
Primary endpoints included determining the maximum tolerated dose (phase 1) and composite complete remission rate (phase 2).
The maximum tolerated dose was not reached, and dose level 3 (cytarabine 1000 mg/m²) was deemed safe for phase 2.
Composite complete remission rate was 75% (41 of 55 patients), showing promising activity.
Common adverse events included febrile neutropenia (53%), pneumonia (22%), and sepsis (22%).
Four treatment-related deaths were reported (3 due to sepsis, 1 due to pneumonia).
The regimen appears safe and effective, potentially serving as a bridge to allogeneic hematopoietic cell transplantation (HCT).
Funding was provided by AbbVie, and the trial is registered under NCT04330820.

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