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
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Eastern Health - Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Barwon Health Coordinator of this site? Confirm its status | Geelong | Australia | Recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Antwerp University Hospital (UZA) Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| University Hospital (UZ) Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CHRU de Tours- Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| St James's University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| Royal Marsden Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Centro Riferimento Oncologico - Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Hospital de Braga Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Champalimaud Cancer Center Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Centro Hospitalar de Vila Nova de Gaia/Espinho EPE Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Goshen Center for Cancer Care Coordinator of this site? Confirm its status | Goshen | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.