Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL

This is a Phase I/II study. The Phase I part will evaluate the safety and tolerability of sonrotoclax in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), using a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The Phase II part will assess the efficacy of the combination regimen in patients with previously untreated LBCL with high BCL2 expression or MYC/BCL2 rearrangements.

NCT Number	NCT07638787
Lead Sponsor	Ruijin Hospital
Conditions	Large B-cell Lymphoma
Enrollment	40 participants
Start Date	2026-06-15
Primary Completion	2027-09-30 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-30