An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)
Stopped early · Phase 1/Phase 2
Conditions studied: Relapsed or Refractory Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)
In brief
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).
Key facts
- Study ID
- NCT04113616
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 70
- Starts
- 2019-09-25
- Expected to finish
- 2023-09-27
- Last updated by the study team
- 2024-03-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Mount Sinai — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Weill Cornell — New York, New York, United States
- The Ohio State University — Columbus, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Monash Health — Clayton, Australia
- St. George Hospital — Kogarah, Australia
- Royal Perth Hospital — Perth, Australia
- Calvary Mater Newcastle Hospital — Waratah, Australia
- Perth Blood Institute — West Perth, Australia
- Institut Jules Bordet — Anderlecht, Belgium
- Cliniques universitaires Saint-Luc — Brussels, Belgium
- UZ Gent — Ghent, Belgium
- Centre Hospitalier (CH) Jolimont — Haine-Saint-Paul, Belgium
- AZ Turnhout — Turnhout, Belgium
- Centre Hospitalier Universitaire (CHU) de Bordeaux — Bordeaux, France
- Institut Paoli Calmettes — Marseille, France
- Centre Hospitalier Universitaire (CHU) de Nice — Nice, France
- Hôpital Saint-Louis — Paris, France
- Universitätsklinikum Halle — Halle, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- University Hospital Jena — Jena, Germany
- University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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