Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan;114(1):17-25.
doi: 10.1111/ejh.14302. Epub 2024 Sep 9.

Venetoclax Combined With FLAG-IDA in Refractory or Relapsed Acute Myeloid Leukemia

Kai Wille  1 , Marvin Dumke  1 , Nadine Wilsdorf  1 , Parvis Sadjadian  1 , Artur Schneider  1 , Stephanie Jender-Bartling  1 , Vera Kolatzki  1 , Anette Horstmann  1 , Raphael Meixner  2 , Marina Jiménez-Muñoz  2 , Christiane Fuchs  2   3 , Hans-Joachim Tischler  1 , Martin Griesshammer  1
Affiliations

Venetoclax Combined With FLAG-IDA in Refractory or Relapsed Acute Myeloid Leukemia

Kai Wille et al. Eur J Haematol. 2025 Jan.

Abstract

Introduction: The prognosis of patients with refractory or relapsed AML (R/R-AML) is very limited. To (re)achieve complete remission, there has recently been increasing evidence that the combination of venetoclax (VEN) with chemotherapy is associated with improved outcomes.

Patients and methods: Our retrospective, single-center study of 53 R/R-AML patients with a median follow-up time of 11.0 months compared standard salvage chemotherapy (FLAG-Ida or HAM in n = 35 patients) with a combination of venetoclax (VEN) and FLAG-Ida (FLAVIDA in n = 18 patients) concerning safety and efficacy.

Results: Regarding the primary endpoints, there was a statistically significant increased event free survival (EFS) in the FLAVIDA group compared to patients with standard chemotherapy based on the univariate log-rank-test and in the multivariate Cox regression analysis (HR 0.22 [95% CI 0.05, 0.97]). There were no differences between the two groups in terms of patients developing febrile neutropenia CTCAE III° and IV° or a delay in hematological recovery. In addition, a clear trend towards an improved overall response rate (78% vs. 51%) was demonstrated in the FLAVIDA group.

Conclusions: The FLAVIDA regimen represents a promising treatment alternative for R/R AML patients with a high response rate and significantly improved EFS compared to standard chemotherapy.

Keywords: FLAVIDA; acute myelocytic leukemia (AML) leukemia; refractory; relapsed; venetoclax.

PubMed Disclaimer

Conflict of interest statement

Dr. Wille declares funding, advisory board honoraria and other financial support (e.g., travel support) from Amgen, AOP Orphan, Novartis, BMS, AbbVie, Pfizer, Roche, Janssen, Gilead, AstraZeneca, Lilly. Professor Dr. Griesshammer declares funding, advisory board honoraria and other financial support (e.g., travel support) from Amgen, AOP Orphan, Novartis, BMS, AbbVie, Pfizer, Roche, Janssen, Gilead, AstraZeneca, Sierra, Lilly. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Kaplan–Meier curves of 6‐month event free survival (EFS) for n = 18 R/R AML patients receiving FLAVIDA (blue curve) compared to n = 35 receiving standard chemotherapy (red curve). EFS is the time from the start of treatment for R/R‐AML until refractory disease, relapse, or death, whichever occurred first. The EFS distributions differ significantly between the FLAVIDA and the standard chemotherapy group (p = 0.04, two‐sided log‐rank test).
FIGURE 2
FIGURE 2
Kaplan–Meier curves of 6‐month overall survival (OS) for n = 18 R/R AML patients receiving FLAVIDA (blue curve) compared to n = 35 with standard chemotherapy (red curve). OS is the time from the start of treatment for R/R‐AML to death. The OS differences in the distributions are not statistically significant (p = 0.27, two‐sided log‐rank test).
See this image and copyright information in PMC

References

    1. Rai K. R., Holland J. F., Glidewell O. J., et al., “Treatment of Acute Myelocytic Leukemia: A Study by Cancer Leukemia Group B,” Blood 58 (1981): 1203–1212. - PubMed
    1. Burnett A. K., Russel N. H., Hills R. K., et al., “A Randomized Comparison of Daunorubicin 90 mg/m2 vs 60 mg/m2 in AML Induction: Results From the UK NCRI AML17 Trial in 1206 Patients,” Blood 125 (2015): 3878–3885. - PMC - PubMed
    1. Rollig C., Bornhauser M., Thiede C., et al., “Long‐Term Prognosis of Acute Myeloid Leukemia According to the New Genetic Risk Classification of the European LeukemiaNET Recommendations: Evaluation of the Proposed Reporting System,” Journal of Clinical Oncology 29 (2011): 2758–2765. - PubMed
    1. Döhner H., Estey E. H., Amadori S., et al., “Diagnosis and Management of Acute Myeloid Leukemia in Adults: Recommendations From an International Expert Panel, on Behalf of the European LeukemiaNet,” Blood 115, no. 3 (2010): 453–474. - PubMed
    1. Thol F. and Heuser M., “Treatment for Relapsed/Refractory Acute Myeloid Leukemia,” Hemsphere 5, no. 6 (2021): e572. - PMC - PubMed

MeSH terms

Supplementary concepts