TL-895 and KRT-232 Study in Acute Myeloid Leukemia
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.
Key facts
- Study ID
- NCT04669067
- Run by
- Telios Pharma, Inc.
- People needed
- 18
- Starts
- 2021-03-31
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2023-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- TP53 wildtype AML
- Relapsed/Refractory to at least one prior therapy, one of which must have included a FLT-3 inhibitor
- FLT3 mutation (FLT3-TKD or FLT3-ITD)
- ECOG 0-2
- Adequate hematologic, hepatic, and renal functions
You may not qualify if…
- AML subtype 3
- Prior treatment with MDM2 antagonist therapies
- Eligible for HSCT
Where it is running
- Keck School of Medicine — Los Angeles, California, United States
- University of California, Irvine Medical Center — Orange, California, United States
- Georgia Cancer Center — Augusta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Rush University Medical Center, Division of Hematology Oncology and Cell Therapy — Chicago, Illinois, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Weill Cornell Medical College — New York, New York, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization — Philadelphia, Pennsylvania, United States
- UT Southwestern Medical Center, Harold C. Simmons Cancer Center — Dallas, Texas, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- University of Sunshine Coast-Sippy Downs — Sippy Downs, Australia
- Westmead Hospital — Sydney, Australia
- Ordensklinikum Linz GmbH Elisabethinen — Linz, Austria
- Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology — Vienna, Austria
- Claude Huriez Hospital — Lille, France
- South Lyon Hospital Center — Lyon, France
- Paoli-Calmettes Institute — Marseille, France
- University Hospital of Nantes — Nantes, France
- Hospital Center Universitaire De Nice — Nice, France
- Saint-Louis Hospital — Paris, France
- University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology — Halle, Saxony-Anhalt, Germany
- University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine — Essen, Germany
- University Hospital Hamburg-Eppendorf, Department of Internal Medicine II — Hamburg, Germany
- Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation — Hanover, Germany
Full record on ClinicalTrials.gov
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