Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study
NCT07398638 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2026-02-10
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
- 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.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2029-02-28
- Completion
- 2031-02-28
Countries
- China
Study Locations
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