Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL
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: Polatuzumab Vedotin, Rituximab (R), Chidamide.
- Who it may be relevant to
- Registry conditions: Double Expressor DLBCL. Basic parameters: from 60 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
- Center list to be confirmed — check the primary protocol.
- 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 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
Overview
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.
Interventions
- Drug Polatuzumab Vedotin
1.8 mg/kg intravenously on Day 1 of each 21-day cycle. - Drug Rituximab (R)
375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle. - Drug Chidamide
20 mg, po, biw
Primary outcome measures
- DLT for Phase 1b [Time frame: The first cycle after administration (each cycle is 21 days)]
- RP2D for phase Ib [Time frame: The first cycle after administration (each cycle is 21 days)]
- Complete response rate (CRR) for Phase 2 [Time frame: Up to 6 cycles (every cycle is 21 days)]
Secondary outcome measures (4)
- Overall response rate (ORR) [Time frame: Up to 6 cycles (every 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
- 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.
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07415980 · B2025-693