Non Hodgkin Lymphoma Clinical Trial

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Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

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Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

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Eligibility Criteria

Inclusion Criteria:

Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant
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 MDM2 inhibitor
Prior treatment with any BTK inhibitor

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT04502394

Recruitment Status:

Recruiting

Sponsor:

Kartos Therapeutics, Inc.

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There are 4 Locations for this study

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Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
University of Cincinnati
Cincinnati Ohio, 45221, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
UT Southwestern Medical Center
Dallas Texas, 75390, 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
Milano , , Italy
IRCCS Ospedale San Raffaele
Milano , , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , , Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona , , Italy
National Cancer Center
Goyang , , Korea, Republic of
Gachon University Gil Medical Center
Incheon , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk , , Poland
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdańsk , , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii
Gliwice , , Poland
Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii
Krakow , , Poland
Pratia MCM Krakow
Kraków , , 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
Lisboa , , 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
Kantonsspital St. Gallen
Saint 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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT04502394

Recruitment Status:

Recruiting

Sponsor:


Kartos Therapeutics, Inc.

How clear is this clinincal trial information?

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