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SOHO 2026 Annual Meeting
September 9 - 12, 2026 | George R. Brown Convention Center, Houston, Texas
AML - 1299
Actinomycin D in Combination with Low-dose Cytarabine and Venetoclax in Relapsed or Refractory NPM1-mutated Acute Myeloid Leukemia
Poster Presenter
Authors
Part of Topic
Acute Myeloid Leukemia (AML)
INTRODUCTION
Actinomycin D has previously demonstrated antileukemic efficacy in R/R NPM1m AML. Herein, we present our real-world study of Actinomycin D, low-dose cytarabine, and venetoclax (ACTIVE) as salvage treatment in R/R NPM1m AML.
AIM
To evaluate the efficacy and toxicity of the ACTIVE regimen in R/R NPM1m AML.
METHODS
This was a retrospective study. The ACTIVE regimen consisted of Actinomycin D 12.5 mcg/kg (days 1-3 or days 1-2 in patients ≥ 65 years), cytarabine 20 mg/m2 (days 1-10), and Venetoclax 600 mg/d (days 1-14).
Venetoclax was continued for 21 or 28 days if marrow on day 14 showed >5% blasts.
Gilteritinib 80 or 120 mg/d was added to ACTIVE in FLT3 co-mutated cases.
After 1 or 2 ACTIVE cycles, responders proceeded to allogeneic HSCT or continued maintenance with low-dose cytarabine + venetoclax.
We collected baseline characteristics, CRc (CR+CRh+CRi) rate, ORR (CR+CRh+CRi+MLFS), MRD-negativity rate, OS, RFS, 30-day and 60-day mortality rate.
RESULTS
28 R/R NPM1m AML patients were enrolled with a median age of 64 years (20-87) and a median ECOG of 1 (0-3).
75% (21/28) were previously exposed to intensive chemotherapy ± Midostaurin, whereas 25% (7/28) were treated with HMA ± Venetoclax.
FLT3 co-mutations were identified in 64% (18/28), and additional Gilteritinib was used in 57% (16/28).
Extramedullary involvement was confirmed in 21% of cases.
The CRc rate was 81% (21/26), and the ORR was 92% (24/26). 2 patients died prior to the response evaluation.
MRD negativity rate in CRc patients was 62% (13/21).
54% (15/28) of patients were bridged to allogeneic SCT.
The median OS was 17.2 months (7.2 - NR), and the median RFS was 13.9 months (4.5 - NR). The median OS and RFS were not reached in allotransplanted patients.
The 30-day and 60-day mortality rates were 11% (3/28) and 18% (6/28), respectively.
CONCLUSIONS
ACTIVE regimen demonstrates promising efficacy and tolerability in R/R NPM1m AML. Further evaluation in clinical trials is warranted.