Actively Recruiting
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
Eligibility Criteria
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
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
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
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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