Clin2
NCT04988555Possibly a fitRecruiting

Study of an investigational drug for high-risk acute leukemia

Leukemia, Myeloid, AcuteLeukemia, Lymphocytic, AcuteMultiple MyelomaMyelodysplastic Syndromes

Treatments studied

Part of Blood & lymphatic, Cancer, Heart & circulation, Immune system & allergy clinical trials.

This Phase 1/2 study tests enzomenib (DSP-5336) in people with relapsed or hard-to-treat acute leukemia (and, in some places, certain other blood cancers). The goal is to see how the drug works and how safe it is, especially for leukemia cases with specific genetic changes (KMT2A/MLL or NPM1).

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
606 people
Ages
12 years and older
Study type
Interventional

Who can take part

  • You have relapsed or refractory acute leukemia (AML, ALL, or ambiguous type), or in some regions MDS or multiple myeloma
  • Your leukemia must match specific genetic markers, usually KMT2A (MLL) fusion or NPM1 mutation (exact marker depends on the study group)
  • In many groups, your bone marrow must have at least 5% blasts (immature cells)
  • You must be older than 18 (or, in some approved settings, at least 12 and ≥40 kg for monotherapy)
  • Your heart, liver, and kidney tests must meet study safety cutoffs, and prior side effects must mostly be resolved
  • You must be able to safely take oral medicine (if in a pill-only part) and provide a bone marrow sample for genetic testing

View the official record on ClinicalTrials.gov

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Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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