Acute Myeloid Leukemia Clinical Trial

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TL-895 and KRT-232 Study in Acute Myeloid Leukemia

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Summary

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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

AML subtype 3
Prior treatment with MDM2 antagonist therapies
Eligible for HSCT

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04669067

Recruitment Status:

Active, not recruiting

Sponsor:

Telios Pharma, Inc.

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There are 35 Locations for this study

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Keck School of Medicine
Los Angeles California, 90033, United States
University of California, Irvine Medical Center
Orange California, 92868, United States
Georgia Cancer Center
Augusta Georgia, 30912, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Rush University Medical Center, Division of Hematology Oncology and Cell Therapy
Chicago Illinois, 60612, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Weill Cornell Medical College
New York New York, 10065, United States
University of Cincinnati
Cincinnati Ohio, 45219, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia Pennsylvania, 19107, United States
UT Southwestern Medical Center, Harold C. Simmons Cancer Center
Dallas Texas, 75390, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Sunshine Coast-Sippy Downs
Sippy Downs , 4556, Australia
Westmead Hospital
Sydney , 2145, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz , 4020, Austria
Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology
Vienna , 1090, Austria
Claude Huriez Hospital
Lille , 59037, France
South Lyon Hospital Center
Lyon , 48178, France
Paoli-Calmettes Institute
Marseille , 13009, France
University Hospital of Nantes
Nantes , 44000, France
Hospital Center Universitaire De Nice
Nice , 06000, France
Saint-Louis Hospital
Paris , 75010, France
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
Halle Sachsen-Anhalt, 06120, Germany
University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine
Essen , 45147, Germany
University Hospital Hamburg-Eppendorf, Department of Internal Medicine II
Hamburg , 20246, Germany
Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation
Hannover , 30625, Germany
University Hospital Jena, Clinic of Internal Medicine II, Department of Hematology and Medical Oncology
Jena , 07747, Germany
University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona, Haematology Clinic
Ancona , 60126, Italy
Polyclinic S. Orsola-Malpighi, Operative Unit of Hematology
Bologna , 40138, Italy
Romagnolo Scientific Institute of Meldola (IRST) S.r.l., Department of Oncology and Clinical and Experimental Haematology
Meldola , 47014, Italy
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Hospital, Department of Hemato-Oncology
Seoul , 03080, Korea, Republic of
University Hospital Germans Trias i Pujol, Department of Clinical Hematology
Badalona , 08916, Spain
University Hospital Vall d'Hebron
Barcelona , 08035, Spain
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
Valencia , 46010, Spain
Hospital Universitario y Politécnico de La Fe
València , 46026, Spain
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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT04669067

Recruitment Status:

Active, not recruiting

Sponsor:


Telios Pharma, Inc.

How clear is this clinincal trial information?

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