Sumitomo - A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukaemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukaemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation

Sumitomo Pharma America, Inc. is conducting a study in the globe including US, EU and APAC to test a new drug called DSP-5336 for treating certain types of difficult-to-treat blood cancers. The study focuses on acute leukemia, a severe blood cancer that's particularly challenging to treat, especially in older adults. There are two main types: acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), both of which can be life-threatening.The study targets leukemias with specific genetic changes, including alterations in the MLL gene (found in 5-10% of adult cases and more frequently in children) and mutations in the NPM1 gene (present in about 30% of adult AML cases).About 130 patients will be included in Phase 1. Around 1 to 6 patients will be enrolled at each dose level. For Phase 2 about 20 to 40 patients will be included in each of the three arms.The UK is participating in all three parts of the study:1. Phase 1 Testing DSP-5336 alone in patients whose leukemia has returned or not responded to treatment arm A and B.2. Phase 1 Evaluating DSP-5336 in combination with other drugs used for AML (venetoclax/azacitidine or gilteritinib) in adults with difficult-to-treat AML (Arm E and Arm F)3. Phase 2 Assessing DSP-5336 by itself in patients with specific genetic changes who haven't been treated with similar drugs before. (Arm G) relapsed/refractory AML with MLL rearrangement. (Arm H) relapsed/refractory AML with NPM1 mutation. (Arm I) relapsed/refractory ALL with MLL rearrangement.The researchers aim to determine:• The most effective dose of the drug• Its safety profile• How the body processes the drug• Whether it helps control the cancerThis study is important because it targets types of leukemia that are currently hard to treat effectively, potentially offering new hope for patients with limited treatment options.