drugset / Trial / NCT05447663

A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant

NCT05447663 ↗

Phase 1/2 Terminated 8 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with Acute Myeloid Leukemia (AML) who were in remission following allogeneic stem cell transplantation (allo-SCT) but were at high risk for relapse based on the presence of pre-transplant risk factors.

Timeline

Start
2023-02-23
Primary completion
2023-10-26
Completion
2023-10-26

Outcome

Outcome not reported

Stopped (Business): “Study has been stopped following the strategic decision from the Sponsor. Not based on any safety findings or safety concerns with siremadlin.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Siremadlin Small molecule 30 mg —