NCT04502394PHASE1, PHASE2Recruiting

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

Kartos Therapeutics, Inc.

Start Date

2/23/2021

Completion Date

3/1/2024

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)

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

KRT-232

DRUG

acalabrutinib

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Conditions

Diffuse Large B Cell LymphomaChronic Lymphocytic LeukemiaNon Hodgkin Lymphoma

Locations

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

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