Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04835584

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Led by Kartos Therapeutics, Inc. · Updated on 2022-03-21

109

Participants Needed

26

Research Sites

268 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

CONDITIONS

Official Title

KRT-232 and TKI Study in Chronic Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Diagnosed with Philadelphia chromosome-positive, BCR-ABL positive Chronic Myeloid Leukemia in chronic phase (Phase 1b and Phase 2 Arms A and B) or accelerated phase (Phase 2 Arm C only)
  • Resistant (relapsed or refractory) or intolerant to at least one prior Tyrosine Kinase Inhibitor
  • ECOG performance status between 0 and 2
  • Adequate blood, liver, and kidney function
Not Eligible

You will not qualify if you...

  • Patients with Philadelphia chromosome-positive, BCR-ABL positive Chronic Myeloid Leukemia in accelerated phase (Phase 1b and Phase 2 Arms A and B)
  • Patients with Philadelphia chromosome-positive, BCR-ABL positive Chronic Myeloid Leukemia in blast crisis
  • Known T315I mutation
  • Prior treatment with MDM2 antagonist therapies
  • Intolerance to current Tyrosine Kinase Inhibitor therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

University of Alabama Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

3

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

4

Texas Oncology- Sammons CC at Baylor

Dallas, Texas, United States, 75246

Actively Recruiting

5

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

6

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 2C1

Actively Recruiting

7

Centre Leon Berard

Lyon, France, 69008

Actively Recruiting

8

APHM Hopital de la Timone

Marseille, France, 13005

Actively Recruiting

9

Institut Paoli-Calmettes

Marseille, France, 13009

Actively Recruiting

10

Centre Hospitalier Lyon Sud

Saint-Genis-Laval, France, 69310

Actively Recruiting

11

Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

Milan, MI, Italy, 20122

Actively Recruiting

12

Azienda Ospedaliero - Universitaria Mater Domini

Catanzaro, Italy, 88100

Actively Recruiting

13

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola FC, Italy, 47014

Actively Recruiting

14

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

15

Pratia Onkologia Katowice

Katowice, Poland, 40-519

Actively Recruiting

16

National Medical Research Center of Hematology

Moscow, Russia, 125167

Actively Recruiting

17

Almazov National Medical Research Center

Saint Petersburg, Russia, 197341

Actively Recruiting

18

Samara State Medical University

Samara, Russia, 443001

Actively Recruiting

19

Kyungpook National University Hospital

Daegu, South Korea

Actively Recruiting

20

Samsung Medical Center

Seoul, South Korea, 135-710

Actively Recruiting

21

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

22

Severance Hospital

Seoul, South Korea

Actively Recruiting

23

Clínica Universidad de Navarra

Madrid, Navarre, Spain, 28027

Actively Recruiting

24

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

25

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

26

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

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Research Team

J

John Mei

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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