Clinical trial · Interventional
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
NCT07398638CI-TRIAL-00102867not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lisaftoclax | Drug | — | UNRESOLVED |
| POLA-R-CHP | Drug | — | UNRESOLVED |
| R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lisatoclax Combined with R-CHOP or Pola-R-CHP
- description
- In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study. In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study.
- interventionNames
- Drug: R-CHOP
- Drug: POLA-R-CHP
- Drug: Lisaftoclax
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT) for Phase 1b
- timeFrame
- The first cycle (each cycle is 21 days) after lisaftoclax administration.
- description
- To identify the DLT
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.