AALL2121: A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia

The primary endpoints are to determine the recommended phase 2 dose (RP2D) of SNDX-5613 administered in combination with chemotherapy in patients with relapsed or refractory KMT2A-rearranged (KMT2A-R) acute lymphoblastic leukemia (ALL), and to estimate the minimal residual disease (MRD) negative remission rate of patients with R/R infant KMT2A-R ALL treated with SNDX-5613 in combination with chemotherapy. Secondary endpoints include characterizing the pharmacokinetics (PK) of SNDX-5613 administered with chemotherapy in patients with R/R infant KMT2A-R ALL, estimating the 18-month event-free survival (EFS) of patients with R/R infant KMT2A-R ALL treated with SNDX5613 in combination with chemotherapy, estimating 18-month overall survival (OS) of patients with R/R infant KMT2A-R ALL treated with SNDX5613 in combination with hemotherapy, and characterizing the tolerability of SNDX-5613 given as monotherapy in patients with R/R infant KMT2A-R ALL. The exploratory endpoint is to assess the biologic activity of SNDX-5613 administered with chemotherapy in patients with R/RKMT2A-R ALL.