Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: R-CHOP, POLA-R-CHP, Lisaftoclax.
- Who it may be relevant to
- Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
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.
Primary outcome measures
- Dose-limiting toxicity (DLT) for Phase 1b [Time frame: The first cycle (each cycle is 21 days) after lisaftoclax administration.]
- Complete response rate (CRR) for Phase 2 [Time frame: Up to 8 cycles (each cycle is 21 days)]
Secondary outcome measures (4)
- Overall response rate (ORR) [Time frame: Up to 8 cycles (each cycle is 21 days)]
- Duration of Response (DOR) [Time frame: Up to 5 years]
- Progression-free survival (PFS) [Time frame: Up to 5 years]
- Overall survival (OS) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 1\. Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures.
- 2\. Diagnosed with DLBCL according to 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center. For the dose-expansion phase, BCL-2 positivity (≥50% by IHC) is required.
- 3\. Age 18-70 years.
- 4\. No prior systemic anti-lymphoma therapy.
- 5\. Adequate organ and bone marrow function.
- 6\. At least one measurable or evaluable disease site according to the Lugano 2014 lymphoma efficacy evaluation criteria.
- 7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
- 1\. Lymphoma involvement in the central nervous system or meninges.
- 2\. Active infections.
- 3\. Uncontrolled clinical cardiac symptoms or diseases.
- 4\. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
- 5\. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- 6\. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- 7\. Patients with mental disorders or those unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07398638 · B2025-809