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ASH 2023 | VENTOGRAFT trial: AZA, VEN, and DLI in patients with MDS and AML who have relapsed following alloSCT

Thomas Cluzeau, MD, PhD, Central University Hospital of Nice, Nice, France, discusses the preliminary findings of the VENTOGRAFT trial (NCT05226455), a Phase I/II trial which is assessing a combination of azacitidine (AZA), venetoclax (VEN), and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) who had relapsed following allogeneic stem cell transplantation (alloSCT). Safety signals were positive in the dose escalation phase of the trial, and the overall response rate (ORR) was encouraging. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (edited for clarity)

So, during this meeting, I presented the preliminary results of the VENTOGRAFT study. It’s a study from the French group of myelodysplasia. The aim of the study was to evaluate the combination of azacitidine plus venetoclax plus donor lymphocyte infusion in patients in relapse after allo stem cell transplantation for MDS and AML. So, in this presentation, I presented the preliminary results from the Phase I...

So, during this meeting, I presented the preliminary results of the VENTOGRAFT study. It’s a study from the French group of myelodysplasia. The aim of the study was to evaluate the combination of azacitidine plus venetoclax plus donor lymphocyte infusion in patients in relapse after allo stem cell transplantation for MDS and AML. So, in this presentation, I presented the preliminary results from the Phase I. In this Phase I, there were three dose levels. So for venetoclax: venetoclax 100mg per day for 14 days, venetoclax 200mg per day for 14 days, and the last level was venetoclax of 400mg per day for 14 days. During this Phase I, we observed only one DLT at dose level three. So, we need to include three more patients. So, for the moment, we have finished the Phase I part, so 12 patients were included in this clinical trial, and we could define the MTD for the Phase II part. So the MTD was the level three, so 400mg per day for 14 days. And the preliminary results show very promising results with an overall response rate of 67%. For the moment, of course, we have no survival data, but it’s really encouraging in this very poor patient [population].

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Disclosures

Consultancy: Jazz Pharma, Abbvie, Novartis, Servier, BMS
Speakers Bureau: Jazz Pharma, Abbvie, Novartis, Servier, Incyte, BMS, Keros, Syros