NCT04502394Recruiting
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
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)
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Italy, United States, Australia, Belgium, Czechia, Poland, Portugal, South Korea, United Kingdom
- Sponsor
- Kartos Therapeutics, Inc.(Industry)
- Protocol no.
- KRT-232-111
- Conditions
- Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
- Interventions
- Drug
Treatments studied
- KRT-232
- acalabrutinib
Locations · 45
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Nantes, FranceCHU de Nantes - Hôtel-DieuRecruiting at this site
- Rouen, FranceCentre Henri BecquerelRecruiting at this site
- Tours, FranceCHRU de Tours - Hôpital BretonneauRecruiting at this site
- Aviano, ItalyCentro Riferimento Oncologico - AvianoRecruiting at this site
- Meldola, ItalyIstituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting at this site
- Milan, ItalyASST Grande Ospedale Metropolitano NiguardaRecruiting at this site
- Milan, ItalyIRCCS Ospedale San RaffaeleRecruiting at this site
- Pavia, ItalyFondazione IRCCS Policlinico San MatteoRecruiting at this site
- Verona, ItalyCentro Ricerche Cliniche di Verona s.r.l.Recruiting at this site
- Goshen, United StatesGoshen Center for Cancer CareRecruiting at this site
- Cincinnati, United StatesUniversity of CincinnatiRecruiting at this site
- Columbus, United StatesThe Ohio State University Comprehensive Cancer CenterRecruiting at this site
- Dallas, United StatesUT Southwestern Medical CenterRecruiting at this site
- Adelaide, AustraliaRoyal Adelaide HospitalRecruiting at this site
- Box Hill, AustraliaEastern Health - Box Hill HospitalRecruiting at this site
- Geelong, AustraliaBarwon HealthRecruiting at this site
- Perth, AustraliaRoyal Perth HospitalRecruiting at this site
- Edegem, BelgiumAntwerp University Hospital (UZA)Recruiting at this site
- Hasselt, BelgiumJessa ZiekenhuisRecruiting at this site
- Leuven, BelgiumUniversity Hospital (UZ) LeuvenRecruiting at this site
- Nový Hradec Králové, CzechiaFakultni Nemocnice Hradec KraloveRecruiting at this site
- Ostrava, CzechiaFakultni nemocnice OstravaRecruiting at this site
- Prague, CzechiaVseobecna fakultni nemocnice v PrazeRecruiting at this site
- Gdansk, PolandCopernicus PL Sp. z o.o., Wojewodzkie Centrum OnkologiiRecruiting at this site
- Gdansk, PolandUniwersyteckie Centrum Kliniczne, Klinika Hematologii i TransplantologiiRecruiting at this site
- Gliwice, PolandNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i OnkohematologiiRecruiting at this site
- Krakow, PolandPratia MCM KrakowRecruiting at this site
- Krakow, PolandSzpital Uniwersytecki Krakow - Oddzial Kliniczny HematologiiRecruiting at this site
- Wroclaw, PolandUniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we WroclawiuRecruiting at this site
In total, worldwide, all 45 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: August 4, 2022).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 15 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.