Clinical Trial

Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial.

Active, Not Recruiting Phase 2
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Record status
This record was last updated December 30, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Within this exploratory multicohort phase II trial, SAKK aims to evaluate a PET/CT and ctDNA oriented therapy in DLBCL in order to test the following working hypothesis. * acalabrutinib-R-CHOP may improve the progression free survival in genetically defined DLBCL harboring the MYD88 L265P and/or CD79A/B mutations; * treatment escalation to acalabrutinib-R-CHOP in DLBCL patients who have positive PET/CT (with residual disease scored as Deauville score 4 or 5 with centrally defined response) and no molecular response (\<2log10 reduction of ctDNA) after two courses of R-CHOP could improve the anti-tumour activity of R-CHOP; * treatment de-escalation to 4 total R-CHOP courses plus 2 rituximab single agent infusions does not compromise the outcome in patients lacking both MYD88 L265P and CD79A/B mutations and quickly obtaining both negative PET/CT (Deauville score 1-3) and molecular response (\>2log10 reduction of ctDNA) after two cycles of R-CHOP.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-10-22; most recent amendment 2025-12-23.
Status change: Recruiting → Active, Not Recruiting 2025-01-08
Status change: Not Yet Recruiting → Recruiting 2021-05-14
Trial Details
NCT Number NCT04604067
Lead Sponsor Swiss Cancer Institute
Conditions Diffuse Large B-cell Lymphoma
Enrollment 260 participants
Start Date 2021-06-25
Primary Completion 2026-07-30 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-30