Smart Conditioning with Venetoclax Enhanced Sequential FLAMSA + RIC in Patients with High-Risk Myeloid Malignancies

Schulz, F.; Jäger, P.; Tischer, J.; Fraccaroli, A.; Bug, G.; Hausmann, A.; Baermann, B.-N.; Tressin, P.; Hoelscher, A.; Kasprzak, A.; Nachtkamp, K.; Schetelig, J.; Hilgendorf, I.; Germing, U.; Dietrich, S.; Kobbe, G. Smart Conditioning with Venetoclax-Enhanced Sequential FLAMSA + RIC in Patients with High-Risk Myeloid Malignancies. Cancers 2024, 16, 532. Schulz, F.; Jäger, P.; Tischer, J.; Fraccaroli, A.; Bug, G.; Hausmann, A.; Baermann, B.-N.; Tressin, P.; Hoelscher, A.; Kasprzak, A.; Nachtkamp, K.; Schetelig, J.; Hilgendorf, I.; Germing, U.; Dietrich, S.; Kobbe, G. Smart Conditioning with Venetoclax-Enhanced Sequential FLAMSA + RIC in Patients with High-Risk Myeloid Malignancies. Cancers 2024, 16, 532.

Abstract

Up to 50% of patients with high-risk myeloid malignancies die of relapse after allogeneic stem cell transplantation. Current sequential conditioning regimens like the FLAMSA protocol combine intensive induction therapy with TBI or alkylators. Venetoclax has synergistic effects to chemotherapy. In a retrospective survey among German transplant centers, we identified 61 patients with myeloid malignancies that had received FLAMSA based sequential conditioning with Venetoclax between 2018 and 2022 as an individualized treatment approach. Sixty patients (98%) had active disease at transplant and 74% had genetic high-risk features. Patients received allografts from matched unrelated, matched related or mismatched donors. Tumor lysis syndrome occurred in two patients but no significant non-hematologic toxicity related to Venetoclax was observed. At day +30, 55 patients (90%) were in complete remission. Acute GvHD II°-IV° occurred in 17 (28%) and moderate/severe chronic GvHD in 7 patients (12%). Event-free survival and overall survival were 64% and 80% at 1 year as well as 57% and 75% at 2 years, respectively. The combination of sequential FLAMSA-RIC with Venetoclax appears to be safe and highly effective. To further validate these insights and enhance the idea of smart conditioning, a controlled prospective clinical trial has been initiated in 07/2023.

Keywords

FLAMSA; allogeneic transplant (aHSCT); sequential conditioning; AML; MDS; myeloid malignancies; reduced-intensity conditioning; RIC; Venetoclax

Subject

Medicine and Pharmacology, Hematology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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