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

Recruiting now · Phase 1/Phase 2

Conditions studied: Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma

In brief

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)

Key facts

Study ID

NCT04502394

Run by

Kartos Therapeutics, Inc.

People needed

84

Starts

2021-02-23

Expected to finish

2024-03-01

Last updated by the study team

2022-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Goshen Center for Cancer Care — Goshen, Indiana, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Royal Adelaide Hospital — Adelaide, Australia (enrolling)
• Eastern Health - Box Hill Hospital — Box Hill, Australia (enrolling)
• Barwon Health — Geelong, Australia (enrolling)
• Royal Perth Hospital — Perth, Australia (enrolling)
• Antwerp University Hospital (UZA) — Edegem, Belgium (enrolling)
• Jessa Ziekenhuis — Hasselt, Belgium (enrolling)
• University Hospital (UZ) Leuven — Leuven, Belgium (enrolling)
• Fakultni Nemocnice Hradec Kralove — Nový Hradec Králové, Czechia (enrolling)
• Fakultni nemocnice Ostrava — Ostrava, Czechia (enrolling)
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia (enrolling)
• CHU de Nantes - Hôtel-Dieu — Nantes, France (enrolling)
• Centre Henri Becquerel — Rouen, France (enrolling)
• CHRU de Tours - Hôpital Bretonneau — Tours, France (enrolling)
• Centro Riferimento Oncologico - Aviano — Aviano, Italy (enrolling)
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy (enrolling)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
• IRCCS Ospedale San Raffaele — Milan, Italy (enrolling)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (enrolling)
• Centro Ricerche Cliniche di Verona s.r.l. — Verona, Italy (enrolling)
• Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii — Gdansk, Poland (enrolling)
• Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii — Gdansk, Poland (enrolling)

Full record on ClinicalTrials.gov

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