Photo Credit: Meletios Verras

The following is a summary of “Venetoclax plus decitabine as a bridge to allogeneic haematopoietic stem-cell transplantation in older patients with acute myeloid leukaemia (VEN-DEC GITMO): final report of a multicentre, single-arm, phase 2 trial,” published in the September 2024 issue of Hematology by Russo et al.   

Access to allogeneic hematopoietic stem-cell transplantation (HSCT) remains difficult for older patients (aged >60 years) with acute myeloid leukemia (AML).  

Researchers conducted a prospective study to evaluate the efficacy of venetoclax plus decitabine as first-line therapy for older patients with AML.  

They conducted a multicenter, single-arm, phase 2 trial across 20 Gruppo Italiano Trapianto Midollo Osseo (GITMO) centers in Italy, enrolling patients aged ≥60 and <75 years with newly diagnosed AML classified as intermediate or high risk according to the 2016 WHO and 2017 European LeukemiaNet criteria. Participants received oral venetoclax, beginning with a 3-day ramp-up (100 mg on day 1, 200 mg on day 2, and 400 mg daily starting from day 3) and intravenous decitabine (20 mg/m² from days 1 to 5), with subsequent cycles occurring every 28 days.  

The results showed, 93 patients began treatment with venetoclax plus decitabine induction, with 44 patients (47% at intermediate risk and 49 patients (53 =%) at high risk (June 1, 2021, and December 30, 2022). The median age was 68.5 years (IQR 60.3–74.7), and all participants were White, including 43 females (46%) and 50 males (54%). The median follow-up was 236 days (IQR 121–506). Of the patients, 64 (69%) achieved complete remission, and 53 (57 %) underwent allogeneic HSCT in remission. Among those in remission, 53 patients (83%) received transplantation, and 5 patients (8%) relapsed before transplantation, resulting in 4 deaths. The AEs of grade 3 or higher occurred in 49 patients (53%). Common AEs included infections (7 deaths among 28 patients, or 57 percent), neutropenia (17 patients, or 35%), thrombocytopenia (2 patients, or 4%), and cardiac events (4 patients, or 8%) with no treatment-related deaths were observed. 

They concluded that venetoclax plus decitabine can significantly improve the likelihood of successful allogeneic hematopoietic stem cell transplantation in older patients with AML deemed fit for treatment.  

Source: thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00241-2/abstract