Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04988555
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2021-07-26
Brief Title:
A Study of DSP-5336 in Relapsedrefractory AML ALL with or Without MLL Rearrangement or NPM1 Mutation
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Phase 12 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 12 dose escalation dose expansion study of DSP 5336 in patients with relapsed or refractory AML
Detailed Description:
Phase 1 dose escalation will determine the recommended Phase 2 dose RP2D ie the lowest dose of DSP 5336 that provides the maximum biologic and clinical effect or the MTD whichever is lower in adult patients with relapsed or refractory 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
Phase 2 dose-expansion will further evaluate the safety and clinical activity of DSP 5336 in adult patients with relapsed or refractory MLLr AML or NPM1m AML
Phase 2 dose-expansion will further evaluate the safety and clinical activity of DSP 5336 in adult patients with relapsed or refractory MLLr AML or NPM1m AML
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None