NCT07398638

Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study

A Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Lisatoclax in Combination With R-CHOP or Pola-R-CHP in Patients With Previously Untreated DLBCL

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	R-CHOP	Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
DRUG	POLA-R-CHP	Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
DRUG	Lisaftoclax	Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy.

Timeline

• Start date: 2026-02-28
• Primary completion: 2029-02-28
• Completion: 2031-02-28
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: China