Double Expressor DLBCL
Conditions
Brief summary
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
DRUGPolatuzumab Vedotin
1.8 mg/kg intravenously on Day 1 of each 21-day cycle.
DRUGRituximab (R)
375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.
DRUGChidamide
20 mg, po, biw
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT for Phase 1b | The first cycle after administration (each cycle is 21 days) | To identify the dose-limiting toxicity |
| RP2D for phase Ib | The first cycle after administration (each cycle is 21 days) | To identify the recommended phase 2 dose |
| Complete response rate (CRR) for Phase 2 | Up to 6 cycles (every cycle is 21 days) | The proportion of patients who achieve complete remission (CR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to 6 cycles (every cycle is 21 days) | The proportion of patients who achieve complete response (CR) or partial response (PR). |
| Duration of Response (DOR) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
| Progression-free survival (PFS) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
| Overall survival (OS) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
Contacts
CONTACTQingqing Cai, MD. PhD.
Outcome results
None listed