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NOT YET RECRUITING
NCT07638787
PHASE1/PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: A Single-Arm, Prospective Study of Pola-R-CHP Plus Sonrotoclax in Patients With Previously Untreated Large B-Cell Lymphoma (LBCL) With High BCL2 Expression / Double-Hit Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06-15

Completion Date

2029-04-30

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Sonrotoclax

Sonrotoclax PO will be administered as per the schedule specified in the respective arm.

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China