Acute Myeloid Leukemia Clinical Trial

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)

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Part A: Patients with relapsed or refractory AML, or newly-diagnosed AML secondary to MPN
Part B:Patients with relapsed or refractory AML secondary to MPN (myelofibrosis [MF], polycythemia vera [PV], or essential thrombocythemia [ET]); patients may have been treated with ≥1 prior lines of therapy for their AML secondary to MPN.
Adequate hepatic and renal function
Appropriate prior treatment with an FLT3 or IDH1/2 inhibitor where applicable

Key Exclusion Criteria:

Patients who are TP53 mutation positive
Prior treatment with an MDM2 antagonist therapy
Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for Part A) .
Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A) .
Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A)
Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B)
Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study
Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study.
Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis
Patients who have had major surgery within 28 days prior to the first treatment with KRT-232
Women who are pregnant or breastfeeding

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

86

Study ID:

NCT04113616

Recruitment Status:

Recruiting

Sponsor:

Kartos Therapeutics, Inc.

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There are 35 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell
New York New York, 10065, United States
The Ohio State University
Columbus Ohio, 43210, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Monash Health
Clayton , , Australia
St. George Hospital
Kogarah , , Australia
Royal Perth Hospital
Perth , 6000, Australia
Calvary Mater Newcastle Hospital
Waratah , 2298, Australia
Perth Blood Institute
West Perth , 6005, Australia
Institut Jules Bordet
Anderlecht , 1070, Belgium
Cliniques universitaires Saint-Luc
Brussels , , Belgium
UZ Gent
Ghent , , Belgium
Centre Hospitalier (CH) Jolimont
Haine-Saint-Paul , 7100, Belgium
CHU-UCL Namur site Godinne
Namur , , Belgium
AZ Turnhout
Turnhout , , Belgium
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux , 33000, France
Institut Paoli Calmettes
Marseille , 13009, France
Centre Hospitalier Universitaire (CHU) de Nice
Nice , 06000, France
Hôpital Saint-Louis
Paris , , France
Universitätsklinikum Halle
Halle , , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg , , Germany
University Hospital Jena
Jena , 07747, Germany
Universitätsklinikum Leipzig
Leipzig , , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck , , Germany
Semmelweis Egyetem
Budapest , 1085, Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologi
Budapest , , Hungary
szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház
Debrecen , , Hungary
Somogy Megyei KAposi Mor Oktato Korhaz
Kaposvár , 7400, Hungary
Rambam Health Care Campus
Haifa , 31096, Israel
Hadassah Medical Center Ein Kerem
Jerusalem , , Israel
The Chaim Sheba Medical Center
Ramat Gan , 52656, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Assaf Harofeh Medical Center AHMC
Tel Aviv , , Israel
Universitaria Maggiore della Carità Novara
Novara Piemonte, 28100, Italy
A.O.O.R. Villa Sofia Cervello
Palermo Sicilia, 90146, Italy
AOU Policlinico S.Orsola-Malpighi
Bologna , , Italy
AORMN Hospital Hematology and BMT Center
Pesaro , , Italy
AOUS Le Scotte
Siena , 53100, Italy
Inje University Busan Paik Hospital
Busan , , Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
The Catholic University of Korea-Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdańsk , , Poland
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas , 35010, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario Virgen de la Victoria de Málaga
Málaga , 29010, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
Birmingham Heartlands Hospital
Birmingham , , United Kingdom
University Hospital of Wales
Cardiff , , United Kingdom
The Royal Marsden Hospital
London , SW3 6, United Kingdom
Oxford University Hospitals NHS Trust, Churchill Hospital
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

86

Study ID:

NCT04113616

Recruitment Status:

Recruiting

Sponsor:


Kartos Therapeutics, Inc.

How clear is this clinincal trial information?

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