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NCT04502394RecruitingPhase 1/2

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

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

Source: ClinicalTrials.gov · Last updated 4 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
84 (estimated)
First submitted
27 Jul 2020
Start date
23 Feb 2021
Primary completion date
Oct 2022
Lead sponsor
Kartos Therapeutics, Inc.
NCT number
NCT04502394

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 84
  • From 23 Feb 2021 to the primary completion date, Oct 2022
  • 45 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with any MDM2 inhibitor
  • Prior treatment with any BTK inhibitor

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Eastern Health - Box Hill Hospital
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Box HillAustraliaRecruiting
Barwon Health
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GeelongAustraliaRecruiting
Royal Perth Hospital
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PerthAustraliaRecruiting
Antwerp University Hospital (UZA)
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EdegemBelgiumRecruiting
JESSA Ziekenhuis
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HasseltBelgiumRecruiting
University Hospital (UZ) Leuven
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LeuvenBelgiumRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandRecruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
CHU de Nantes - Hôtel Dieu
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NantesFranceRecruiting
Centre Henri Becquerel
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RouenFranceRecruiting
CHRU de Tours- Hopital Bretonneau
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ToursFranceRecruiting
St James's University Hospital
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LeedsUnited KingdomRecruiting
Royal Marsden Foundation Trust
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LondonUnited KingdomRecruiting
King's College Hospital
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LondonUnited KingdomRecruiting
University Hospital Southampton NHS Foundation Trust
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SouthamptonUnited KingdomRecruiting
Centro Riferimento Oncologico - Aviano
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AvianoItalyRecruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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MeldolaItalyRecruiting
IRCCS Ospedale San Raffaele
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyRecruiting
National Cancer Center
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GoyangSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
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GdanskPolandRecruiting
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
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GdanskPolandRecruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii
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GliwicePolandRecruiting
Pratia MCM Krakow
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KrakowPolandRecruiting
Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii
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KrakowPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Hospital de Braga
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BragaPortugalRecruiting
Champalimaud Cancer Center
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LisbonPortugalRecruiting
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
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LisbonPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
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PortoPortugalRecruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
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Vila Nova de GaiaPortugalRecruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
The Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Goshen Center for Cancer Care
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GoshenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.