Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial.
Status:
Recruiting
Trial end date:
2030-12-01
Target enrollment:
Participant gender:
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) 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 R-CHOP, and further improve to
Deauville score 1-2 and absence of ctDNA after two more R-CHOP courses.