Clinical Trial

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

Not Yet Recruiting Phase 1/2
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Summary
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.
Trial Details
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 2026-06-10