Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial

• Authors: ROLLIG C.; STEFFEN B.; ALAKEL N.; HERBST R.; NOPPENEY R.; HANOUN M.; RACIL Z.; SCHAFER-ECKART K.; KRAMER A.; NEUBAUER A.; BALDUS C. D.; SCHLIEMANN C.; KAUFMANN M.; MERTOVA J.; JOST E.; NIEMANN D.; NOVAK J.; KRAUSE S. W.; SCHOLL S.; HELD G.; PARMENTIER S. B.; SZOTKOWSKI T.; ZAK P.; RANK A.; WASS M.; BUSKE S.; KRAMER M.; FIEBIG F.; HAAKE A.; SCHETELIG J.; PLATZBECKER U.; THIEDE C.; MULLER-TIDOW C.; BERDEL W. E.; SERVE H.; EHNINGER G.; MAYER Jiří; BORNHAUSER M.
• Year of publication: 2020
• Type: Conference abstract
• MU Faculty or unit: Faculty of Medicine
• Description: Double induction using two subsequent 7+3 regimens of cytarabine plus anthracycline is commonly performed in AML patients with an adequate performance status in order to maximize dose intensity upfront. However, for patients with a good early response at day 15 of first induction, there is no prospective randomized evidence on the necessity or value of a second induction cycle. In order to answer the question if good responders of the first 7+3 induction could be spared a second induction cycle, we set up randomized-controlled SAL DaunoDouble trial. The study prospectively assesses the outcome of patients with a good early response with respect to the number of induction cycles (single versus double). We assumed non-inferiority of single induction in terms of complete remission (CR/CRi) rate, based on a margin of 7.5%. Here, we present the results of the planned interim analysis.

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