RecruitingPhase 3NCT05820841

Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma

A Randomized, Open-label, Phase 3 Study of Acalabrutinib in Combination With Rituximab and Reduced Dose CHOP (R-miniCHOP) in OldEr Adults With Untreated Diffuse Large B-Cell Lymphoma


Sponsor

Universität des Saarlandes

Enrollment

330 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.


Eligibility

Min Age: 61 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding acalabrutinib — a targeted drug that blocks a protein called BTK involved in blood cancer cell survival — to a gentler version of standard chemotherapy (called R-miniCHOP) can improve outcomes for older or frail adults with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL). **You may be eligible if...** - You are 60 years or older, OR are younger but have significant health conditions that make standard-intensity chemotherapy too risky - You have been newly diagnosed with DLBCL (a type of fast-growing lymphoma) - You have not yet received treatment for this cancer - Your heart function is adequate (ejection fraction ≥ 50%) **You may NOT be eligible if...** - You have received prior treatment for this lymphoma - You have a serious infection or uncontrolled illness - You have significant heart rhythm problems or take medications that could interact with the study drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-miniCHOP + Acalabrutinib

* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5) * Acalabrutinib 100 mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously to D21 of cycle 8. Cycles repeated every 3 weeks

DRUGR-miniCHOP

* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5). Cycles repeated every 3 weeks


Locations(17)

Saarland University Medical Center

Homburg, Saarland, Germany

MVZ am Klinikum Aschaffenburg

Aschaffenburg, Germany

Helios Klinikum Emil von Behring

Berlin, Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, Germany

Gemeinschaftspraxis Mohm/Prange-Krex

Dresden, Germany

Universitätsklinikum Gießen und Marburg, Standort Gießen

Giessen, Germany

Universitätsmedizin Greifswald

Greifswald, Germany

Universitätsmedizin Halle (Saale)

Halle, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Johannes Wesling Klinikum

Minden, Germany

Rheinland Klinikum-Lukaskrankenhaus Neuss

Neuss, Germany

Brüderkrankenhaus St. Josef

Paderborn, Germany

CaritasKlinikum Saarbrücken St. Theresia

Saarbrücken, Germany

Klinikum Mutterhaus der Borromäerinnen

Trier, Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Bundeswehrkrankenhaus Ulm

Ulm, Germany

Universitätsklinikum Ulm

Ulm, Germany

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NCT05820841


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