Clinical trial · Interventional
Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL
A Multicenter, Phase Ib/II Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2
NCT07415980CI-TRIAL-00103346not 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 single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.
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 |
|---|---|---|---|
| Double Expressor DLBCL | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Rituximab (R) | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Polatuzumab Vedotin in Combination With Rituximab and Chidamide
- description
- Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.
- interventionNames
- Drug: Polatuzumab Vedotin
- Drug: Rituximab (R)
- Drug: Chidamide
Primary outcomes (3)
- measure
- DLT for Phase 1b
- timeFrame
- The first cycle after administration (each cycle is 21 days)
- description
- To identify the dose-limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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; * Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA). * Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma. * At least one measurable or evaluable lesion according to the Lugano 2014 criteria. * No prior systemic therapy for DLBCL. * Adequate organ and bone marrow function. Exclusion Criteria: * Other subtypes of DLBCL. * Lymphoma involvement in the central nervous system or meninges. * Active infections. * History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS). * Patients with mental disorders or those unable to provide informed consent * Any other condition deemed by the investigator to be unsuitable for study enrollment. * Known hypersensitivity to any investigational drug.
References
Publications (0)
Data not yet available
No reference posted for this study.