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ASH 2025 | cAMeLot-2: Phase III trial of bleximenib + venetoclax + azacitidine in AML with KMT2A/NPM1 mutations
Elias Jabbour, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, shares insight into the cAMeLot-2 trial (NCT06852222), a randomized Phase III study evaluating the efficacy of bleximenib, venetoclax, plus azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) harboring KMT2A rearrangements or NPM1 mutations, who are ineligible for intensive chemotherapy. The primary endpoints of the study are complete response (CR) and overall survival (OS), with secondary endpoints including duration of CR and safety. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The cAMeLot-2 trial is a randomized Phase III trial, randomizing patients with KR2-RH disease or MDS, which is AML, unfit for intensive chemotherapy to either receive HMA-Ven plus bleximenib or HMA-Ven placebo. So it’s a double-blind study, placebo-controlled. The primary endpoint is CR and overall survival. Secondary endpoints are duration of response, time to response, and monitoring activities, safety, and others, like any other trial...
The cAMeLot-2 trial is a randomized Phase III trial, randomizing patients with KR2-RH disease or MDS, which is AML, unfit for intensive chemotherapy to either receive HMA-Ven plus bleximenib or HMA-Ven placebo. So it’s a double-blind study, placebo-controlled. The primary endpoint is CR and overall survival. Secondary endpoints are duration of response, time to response, and monitoring activities, safety, and others, like any other trial. This study is a multi-center trial. It’s a global study designed to get all 600 patients. And this was based on a single-arm trial, proving that azacitidine-venetoclax is highly effective and it doesn’t add toxicities to azacitidine. So the study will enroll 600 patients and hopefully will improve the results and lead to the approval of a maximum in a frontline setting in this patient population.
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