Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
NCT ID: NCT04502394
Last Updated: 2022-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2021-02-23
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (R/R DLBCL)
KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.
Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
acalabrutinib
acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
Cohort 2 (R/R CLL)
KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.
Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
acalabrutinib
acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
Interventions
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KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
acalabrutinib
acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment
* ECOG 0 to 2
* Adequate hematologic, hepatic, and renal functions.
Exclusion Criteria
* Prior treatment with any BTK inhibitor
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Goshen Center for Cancer Care
Goshen, Indiana, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Royal Adelaide Hospital
Adelaide, , Australia
Eastern Health - Box Hill Hospital
Box Hill, , Australia
Barwon Health
Geelong, , Australia
Royal Perth Hospital
Perth, , Australia
Antwerp University Hospital (UZA)
Edegem, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
University Hospital (UZ) Leuven
Leuven, , Belgium
Fakultni Nemocnice Hradec Kralove
Nový Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
CHU de Nantes - Hôtel-Dieu
Nantes, , France
Centre Henri Becquerel
Rouen, , France
CHRU de Tours - Hôpital Bretonneau
Tours, , France
Centro Riferimento Oncologico - Aviano
Aviano, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, , Italy
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii
Gliwice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii
Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Champalimaud Cancer Center
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
Vila Nova de Gaia, , Portugal
National Cancer Center
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
St James's University Hospital
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Marsden Foundation Trust
London, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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KRT-232-111
Identifier Type: -
Identifier Source: org_study_id
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