drugset / Trial / NCT04623216

Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

NCT04623216

Phase 1/2 Terminated 24 enrolled Novartis Pharmaceuticals
RandomizedSequentialOpen-labelTreatment

Summary

The primary purpose of this study was to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with Acute myeloid leukemia (AML)/secondary AML who were in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (Minimal residual disease (MRD)+ post- Allogeneic hematopoietic stem cell transplantation (aHSCT)), could enhance the graft versus leukemia (GvL) response and prevent or delay hematologic relapse without an unacceptable level of treatment-emergent toxicities, including clinically significant acute and/or chronic graft-versus-host disease (GvHD) and immune-related adverse events

Timeline

Start
2021-09-14
Primary completion
2024-08-22
Completion
2024-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified Intravenous
Subject Sabatolimab Monoclonal antibody 400 mg Intravenous
Subject Sabatolimab Monoclonal antibody 800 mg Intravenous