Study DSP-5336-101 is a Phase 1/2, open-label, dose-escalation, dose-expansion study in which the safety, PK, pharmacodynamics, and clinical activity of orally administered DSP-5336 will be evaluated in adult patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage, as well as in adult patients with high-risk relapsed or refractory MDS or relapsed/refractory MM. The study includes a Phase 1 dose escalation portion- in patients with AML, ALL, acute leukemia of ambiguous lineage, MDS, or MM to determine the RP2D as defined by the maximum biologic effect or the MTD, whichever is lower. The dose will be determined separately for acute leukemia, MDS, and MM.
A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation (DSP-5336-101)
Relapsed refractory myeloma
All genders
18+
Recruiting now
Overview
Principal Investigator: Zheng (Frank) Zhou, MD
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Latoya Lashley
Study details
Inclusion Criteria
- 1. Patients in the Phase 1 dose-escalation portion must have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage, and who failed available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage. Enrollment to the phase 1 portion of the study may be limited to patients with certain genetic abnormalities.
Patients in the Phase 2 dose-expansion portion must have a confirmed diagnosis of relapsed or refractory AML, and who failed available standard therapies known to be active for their AML. They must also have a documented KMT2A (MLL)-fusion or NPM1 mutation, which includes those with coexisting FLT3 genomic alterations and/or IDH1/2 mutations.
- 2. ECOG < 2
- 3. WBC below 30,000/μL (hydroxyurea allowed prior to initiation of the study treatment)
Exclusion Criteria
- 1. Has a left ventricular ejection fraction (LVEF) <45%, as determined by ECHO
- 2. Histological diagnosis of acute promyelocytic leukemia
- 3. Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP 5336
Study Requirements
Patients in both the dose-escalation (Phase 1) portion and the dose-expansion (Phase 2) portion of the study will undergo the following: - Screening period of up to 21 days - Treatment period that will continue as long as the patient is benefitting from treatment and does not experience a dose-limiting toxicity (DLT) or serious adverse event (SAE) that requires discontinuation of study drug - an End-of-Treatment (EOT) visit within 30 days following the patient’s last dose of study - telephone calls for Survival follow-up every 4 months, or as needed, up to 24 months from the EOT visit The overall planned study duration, including the above visits and periods, is 50 months (4.2 years).