EHA 2026 | ARCHIVE conditioning enables direct-to-transplant strategy in high-risk AML

When we’re talking about relapsed refractory patients, we are usually talking about bridging them to a transplant. So our institutional study is actually, we try, we aim to change the paradigm, is just not to build a bridge for a patient, but take the transplant from one coast and bring it to the patient where he’s standing right now in his need of a transplant because the bridging therapies are actually can be ineffective and toxic sometimes both of them right and this unfortunately a proportion of patients after those bridging therapies unfortunately cannot go to a transplant so why not bring the transplant to them but of course we understand that these patients have a very high leukemia burden usually, right? Their bone marrow is full of blasts. They’re clinically in a poor shape. And in this scenario, we are using our own investigational conditioning regimen, which is alkylating agents, cladribine, cytarabine, venetoclax, HMAs, and GCSF. So basically, it’s a two-step approach. It’s an ADA regimen consisting of those drugs, and it’s aiming for leukemia control and also conditioning, creating conditions for the patient to successfully engraft and be transplanted. So after those eight days of conditioning, the patients are infused with the stem cells. We use standard GVHD prophylaxis which is post-transplant cyclophosphamide at a slightly lower dose of 40 milligrams per kg on day plus three plus four and then the standard of care of calcineurin inhibitor and mycophenolate we are very happy to see that after the analysis of 40 patients so we included 40 patients right, the complete remission rate at day 30 post-transplant is actually 97%. So only one patient did not respond and had leukemia regrowth after transplant. So we put almost all patients in CR at day 30 with this approach. Unfortunately, yes, the toxicity was notable. We had 88% of grade 3, 4, or 5 infectious complications. The early mortality was 5% at day 30, so we have lost two patients due to the leukemia regrowth and due to toxicity. Otherwise, later on, we have witnessed a 23% incidence of grade 3, 4 GVHD, which was also notable. Otherwise, the leukemia control was good. Both overall survival and relapse-free survival, the medians are not reached, and we’re very happy to see that. Of course, we individually implement post-transplant care, which also could potentially lower the relapse risk by doing DLIs, by adding HMAs as a maintenance strategy, using FLT3 inhibitors, IDH inhibitors. But basically our study, what we want to translate and show that you can change the paradigm of not building a bridge by just taking the patient to a transplant directly with a two-step approach, both addressing leukemia and the conditioning regimen required for a successful transplant.

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